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Review of Polymorph Patent Application of 30 Small Molecule New Drugs Approved by the FDA in 2023

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    In 2023, the FDA's Center for Drug Evaluation and Research (CDER) approved a total of 55 new drugs, which included 38 new molecular entities, of which 30 were small molecule drugs. In terms of administration routes and dosage forms among these small molecule drugs, there were 5 liquid formulations (including 2 injections and 3 eye drops), 1 nasal spray, and 24 solid/semi-solid formulations (comprising 23 solid dosage forms and 1 gel), as illustrated in Table 1.

     

    Table 1. Basic information of 38 new molecular entities approved by the FDA in 2023

     

    No.

    Brand name

    Active Ingredient

    Innovator

    Indication

    Target

    Drug type

    Dosage form

    1

    Brenzavvy

    Bexagliflozin

    TheracosBio

    Type 2 diabetes mellitus

    SGLT-2

    Small molecule

    Oral solid

    2

    Jaypirca

    Pirtobrutinib

    Eli Lilly

    Mantle Cell Lymphoma

    BTK inhibitor

    Small molecule

    Oral solid

    3

    Orserdu

    Elacestrant

    Stemline Therapeutics

    ER+、HER2-、ESR1 mutated advanced or metastatic breast cancer 

    SERD

    Small molecule

    Oral solid

    4

    Jesduvroq

    Daprodustat

    GSK

    Anemia caused by chronic kidney disease for adults on dialysis for at least four months

    HIF-PHI inhibitor

    Small molecule

    Oral solid

    5

    Filspari

    Sparsentan

    Travere Therapeutics

     Adults with primary immunoglobulin A nephropathy

    Endothelin and angiotensin II receptor antagonist

    Small molecule

    Oral solid

    6

    Skyclarys

    Omaveloxolone

    Reata Pharmaceuticals

    Friedrich’s ataxia

    NF E2 related factor 2 stimulants

    Small molecule

    Oral solid

    7

    Zavzpret

    Zavegepant Hydrochloride

    Pfizer

    Migraine

    CGRP receptor antagonists

    Small molecule

    Nasal spray

    8

    Daybue

    Trofinetide

    Acadia

    Rett syndrome

    Analogue of the neuropeptide (1-3) IGF-1

    Peptide

    Oral solution

    9

    Rezzayo

    Rezafungin Acetate

    Cidara Therapeutics

    Candidemia and invasive candidiasis

    Glucan synthase inhibitors

    Cyclic Peptide

    Injection

    10

    Joenja

    Leniolisib Phosphate

    Pharming

    Activated phosphoinositide 3-kinase delta syndrome

    PI3Kδ inhibitor

    Small molecule

    Oral solid

    11

    Qalsody

    Tofersen

    Biogen

    Amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation

    RNA interference

    ASO

    Injection

    12

    Veozah

    Fezolinetant

    Astellas

    Moderate to severe hot flashes caused by menopause

    Neurokinin 3 receptor antagonists

    Small molecule

    Oral solid

    13

    Miebo

    Perfluorohexyloctane

    Bausch+Lomb Corp. & Novaliq GmbH

    Dry eye disease

    Lipid modulators

    Small molecule

    Eye drops

    14

    Xacduro

    Sulbactam,Durlobactam

    Innoviva

    Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia

    β-lactamase inhibitor

    Small molecule

    Injection

    15

    Posluma

    Flotufolastat F-18 Gallium

    Blue Earth Diagnostics

    Use with positron emission tomography imaging in certain patients with prostate cancer

    Target PSMA

    peptidomimetics

    Injection

    16

    Paxlovid

    Nirmatrelvir,Ritonavir

    Pfizer

    Mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19

    3C protease inhibitor,CYP3A4 protease inhibitor

    Small molecule

    Oral solid

    17

    Inpefa

    Sotagliflozin

    Lexicon

    Heart failure 

    SGLT-1/2 inhibitor

    Small molecule

    Oral solid

    18

    Litfulo

    Ritlecitinib Tosylate

    Pfizer

    Severely patchy hair loss

    JAK3 inhibitor,TEC inhibitor

    Small molecule

    Oral solid

    19

    Vanflyta

    Quizartinib Dihydrochloride

    Daiichi Sankyo

    As part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria

     FLT3 inhibitor

    Small molecule

    Oral solid

    20

    Xdemvy

    Lotilaner

    Tarsus

    Demodex blepharitis

    GABA-A receptor antagonists

    Small molecule

    Eye drops

    21

    Izervay

    Avacincaptad Pegol Sodium

    Iveric Bio

    Geographic atrophy secondary to age-related macular degeneration)

    Complement C5 inhibitor

    Small molecule

    Eye drops

    22

    Zurzuvae

    Zuranolone

    Biogen&Sage Therapeutics

    Postpartum depression 

    GABA A receptor positive allosteric modulator

    Small molecule

    Oral solid

    23

    Aphexda

    Motixafortide Acetate

    BioLineRx

    Multiple myeloma

    CXCR4 inhibitor

     Cyclic peptide

    Injection

    24

    Sohonos

    Palovarotene

    Ipsen

    Reduce the volume of new heterotopic ossification in adults and pediatric patients  with fibrodysplasia ossificans progressiva

    Retinoic acid receptor gamma agonist

    Small molecule

    Oral solid

    25

    Ojjaara

    Momelotinib Dihydrochloride

    GSK

    Intermediate or high-risk myelofibrosis in adults with anemia

    JAK1/JAK2/ALK2 inhibitor

    Small molecule

    Oral solid

    26

    Exxua

    Gepirone Hydrochloride

    Fabre-Kramer Pharmaceuticals

    Major depressive disorder

    5-HT1A serotonin receptor agonist

    Small molecule

    Oral solid

    27

    Rivfloza

    Nedosiran Sodium

    NovoNordisk

    Patients 9 years and older with primary hyperoxaluria type 1

    ASGR1&L-lactate dehydrogenase inhibitor

    siRNA

    Injection

    28

    Velsipity

    Etrasimod Arginine

    Pfizer

    Moderately to severely active ulcerative colitis in adults

    Sphingosine 1 phosphate receptor modulator

    Small molecule

    Oral solid

    29

    Zilbrysq

    Zilucoplan Sodium

    UCB

    Generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive

    Complement C5 inhibitor

     Cyclic peptide

    Injection

    30

    Agamree

    Vamorolone

    Santhera Pharmaceuticals& ReveraGen BioPharma

    Duchenne muscular dystrophy

    Glucocorticoid receptor agonist

    Small molecule

    Oral solid

    31

    Fruzaqla

    Fruquintinib

    Hutchmed&Takeda

    Refractory, metastatic colorectal cancer

    EGFR

    Small molecule

    Oral solid

    32

    Defencath

    Heparin Sodium,Taurolidine

    CorMedix

    Reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter

    AT III agonist, LPS inhibitor

    Small molecule

    Injection

    33

    Augtyro

    Repotrectinib

    BMS

    ROS1-positive non-small cell lung cancer

    ROS1/TRK/ALK protein inhibitor

    Small molecule

    Oral solid

    34

    Truqap

    Capivasertib

    AstraZeneca

    HR+、HER2- breast cancer

    AKT inhibitor

    Small molecule

    Oral solid

    35

    Ogsiveo

    Nirogacestat Hydrobromide

    SpringWorks Therapeutics

    Adults with progressing desmoid tumors who require systemic treatment

    A γ-secretase inhibitor

    Small molecule

    Oral solid

    36

    Fabhalta

    Iptacopan Hydrochloride

    Novartis

    Paroxysmal nocturnal hemoglobinuria

    Factor B inhibitor

    Small molecule

    Oral solid

    37

    Filsuvez

    Birch Triterpenes

    Amryt

    Wounds associated with dystrophic and junctional epidermolysis bullosa

    N/A

    Small molecule

    Gel

    38

    Wainua

    Eplontersen

    AstraZeneca & Ionis

    Polyneuropathy of hereditary transthyretin-mediated amyloidosis

    TTR inhibitor

    ASO

    Injection

     

    The review of polymorph patent fillings for the 24 solid or semi-solid small molecule new drugs revealed that polymorph patents had been applied for in 20 cases, representing 83% of the total solid or semi-solid small molecule new drugs. Refer to Table 2 for detailed information.

     

    Tablet 2. Basic information and polymorph patent information of 24 small molecule new drugs for solid/semi-solid preparations

     

    No.

    Brand name

    Active ingredient

    Innovator

    Polymorph Patent Status

    1

    Brenzavvy

    Bexagliflozin

    TheracosBio

    Granted

    2

    Jaypirca

    Pirtobrutinib

    Eli Lilly

    Partial granted

    3

    Orserdu

    Elacestrant

    Stemline Therapeutics

    Granted

    4

    Jesduvroq

    Daprodustat

    GSK

    Granted

    5

    Filspari

    Sparsentan

    Travere Therapeutics

    Under examination

    6

    Skyclarys

    Omaveloxolone

    Reata Pharmaceuticals

    Granted

    7

    Joenja

    Leniolisib Phosphate

    Pharming

    Withdrawn

    (crystal forms disclosed in compound patent)

    8

    Veozah

    Fezolinetant

    Astellas

    Withdrawn

    9

    Paxlovid

    Nirmatrelvir,Ritonavir

    Pfizer

    Granted

    (crystal forms disclosed in compound patent)

    10

    Inpefa

    Sotagliflozin

    Lexicon

    Granted

    11

    Litfulo

    Ritlecitinib Tosylate

    Pfizer

    Partial granted

    12

    Vanflyta

    Quizartinib Dihydrochloride

    Daiichi Sankyo

    Granted

    13

    Zurzuvae

    Zuranolone

    Biogen&Sage Therapeutics

    Granted

    14

    Sohonos

    Palovarotene

    Ipsen

    Not found

    15

    Ojjaara

    Momelotinib Dihydrochloride

    GSK

    Granted

    16

    Exxua

    Gepirone Hydrochloride

    Fabre-Kramer Pharmaceuticals

    Not found

    17

    Velsipity

    Etrasimod Arginine

    Pfizer

    Granted

    18

    Agamree

    Vamorolone

    Santhera Pharmaceuticals & ReveraGen BioPharma

    Granted

    19

    Fruzaqla

    Fruquintinib

    Hutchmed&Takeda

    Granted

    20

    Augtyro

    Repotrectinib

    BMS

    Granted

    21

    Truqap

    Capivasertib

    AstraZeneca

    Granted

    22

    Ogsiveo

    Nirogacestat Hydrobromide

    SpringWorks Therapeutics

    Granted

    23

    Fabhalta

    Iptacopan Hydrochloride

    Novartis

    Granted

    24

    Filsuvez

    Birch Triterpenes

    Amryt

    Not found

     

    Table 3 provides a detailed analysis of the expiration dates for both compound patents and polymorph patents for these 20 drugs, along with the time gaps between them. It was found that 15 of these drugs have polymorph patents expiring later than their compound patents, with a gap exceeding 1 year. Specifically, 11 drugs show a time difference of 3 or more years, 8 drugs have a gap of 5 or more years, and notably, three drugs (Orserdu, Agamree and Ogsiveo) exhibit a time difference of over 10 years.

     

    Table 3. Analysis of Compound Patents and Polymorph Patents for 20 Small Molecule New Drugs

     

    No.

    Brand name

    Compound patent

    Expiration date[2]

    Polymorph patent

    Expiration date[3]

    Time gap[4](Month)

    1

    Brenzavvy

    US7838499B2

    2029/1/30

    US8987323B2

    2032/5/14

    ~45

    2

    Jaypirca

    US10695323B2

    2036/12/16

    US20210330643A1

    Filing date

    2019/07/29

    N/A

    3

    Orserdu

    US7612114B2

    2026/08/18

    US11643385B2

    2039/7/3

    ~155

    4

    Jesduvroq

    US8324208B2

    2028/12/11

    US11117871B2

    2038/3/13

    ~111

    5

    Filspari

    US6835741B2

    Expired

    US20220048900A1

    Filing date

    2019/12/20

    N/A

    6

    Skyclarys

    US8124799B2

    2029/12/3

    US8993640B2

    2033/4/24

    ~40

    7

    Joenja

    US8653092B2

    2032/2/19

    US20180265509A1

    Filing date

    2011/7/1

    N/A

    8

    Paxlovid

    US11351149B2

    2041/8/5

    US11351149B2

    2041/8/5

    N/A

    9

    Inpefa

    US8476413B2

    2028/5/29

    US8217156B2

    2030/10/7

    ~28

    10

    Litfulo

    US9617258B2

    2034/12/3

    US20210387989A1

    Filing date

    2019/10/21

    N/A

    11

    Vanflyta

    US7820657B2

    2028/9/26

    US8883783B2

    2031/7/12

    ~34

    12

    Zurzuvae

    US9512165B2

    2034/4/17

    US11236121B2

    2037/8/23

    ~40

    13

    Ojjaara

    US8486941B2

    2030/1/3

    US9469613B2

    2035/6/11

    ~65

    14

    Velsipity

    US8580841B2

    2030/3/5

    US10301262B2

    2036/6/21

    ~75

    15

    Agamree

    US3947409A

    Expired

    US11382922B2

    2040/7/16

    >198

    16

    Fruzaqla

    US7829574B2

    2028/5/9

    US10519142B2

    2035/9/7

    ~88

    17

    Augtyro

    US9714258B2

    2035/1/23

    US10294242B2

    2036/7/5

    ~17

    18

    Truqap

    US8101623B2

    2030/3/10

    US9487525B2

    2033/4/16

    ~33

    19

    Ogsiveo

    US7342118B2

    2025/8/18

    US10941118B2

    2039/8/9

    ~168

    20

    Fabhalta

    US9682968B2

    2034/7/14

    US11603363B2

    2041/5/25

    ~82

     

     

    To provide a clearer insight into how innovator companies extend the lifecycles of their products using polymorph patent layouts, we will delve into three representative drugs: Skyclarys, Zurzuvae, Ogsiveo. The authorization of these drugs represents crucial breakthroughs in the treatment of their respective diseases. Additionally, their market share projections highlight their potential to become blockbuster drugs.  

     

    Skyclarys

    Skyclarys (Omaveloxolone) is a drug developed by Reata Pharmaceuticals, a medication approved for the treatment of Friedreich ataxia (FA), a progressive neurodegenerative disorder, in adults and adolescents aged 16 and older. It stands as the sole FDA-approved treatment for this specific condition. Omaveloxolone’s effectiveness is attributed to its dual action: activating the antioxidative transcription factor Nrf2 and inhibiting the pro-inflammatory transcription factor NF-κB. On February 28, 2023, Reata Pharmaceuticals announced the FDA’s approval for Skyclarys, presenting a new avenue for potentially alleviating disease progression in Friedreich ataxia patients. 

    In the commercialized version of the drug, the active ingredient is the crystalline form of Omaveloxolone. The original compound patent (US8124799B2) for this is set to expire on December 3, 2029. Meanwhile, the polymorph patent (US8993640B2), which covers various amorphous and solvent form/hydrates of Omaveloxolone, will expire later on April 24, 2033. The application of the polymorph patent effectively extends the product’s protection by about 40 months.

     

    Zurzuvae

    Zurzuvae (Zuranolone), an oral medication developed by Biogen and Sage Therapeutics, is designed to treat postpartum depression (PPD), a prevalent complication affecting 15%-30% of women during and after pregnancy. Unlike existing antidepressants that often take time to show significant effects, Zurzuvae stands out with its rapid efficacy. It functions as a positive allosteric modulator of γ-aminobutyric acid A (GABAA) receptors and is noted for its high oral bioavailability and affordability. Biogen and Sage Therapeutics received FDA approval for Zurzuvae on August 4, 2023, offering a swift and effective treatment option for those suffering PPD symptoms.

     

    The marketed form of Zurzuvae contains Zuranolone in its crystalline state. Its compound patent (US9512165B2) is set to expire on April 17, 2034. Additionally, the polymorph patent (US11236121B2), which details a range of Zuranolone polymorphs from type A to type P, including anhydrous forms, hydrates, and solvates, will expire on August 23, 2037. By applying the polymorph patent, the protection duration of the product has been effectively extended by around 40 months.

     

    Ogsiveo

    SpringWorks Therapeutics developed Ogsiveo (Nirogacestat Hydrobromide), the first oral tablet for treating desmoid tumors in adult patients. Nirogacestat is a selective inhibitor targeting the gamma secretase (GS) enzyme. It works by binding to GS, which prevents the proteolytic activation of Notch receptors. This inhibition of Notch signaling pathway may lead to apotosis in tumor cells that exhibit excessive Noth expression. On November 28, 2023, SpringWorks Therapeutics announced FDA approval for Ogsiveo, marking it as a treatment option for systemic management of progressive fibrous dysplasia in adults.

     

    The active ingredient in the commercial version of Ogsiveo is the crystalline form of Nirogacestat Hydrobromide. The primary compound patent for Ogsiveo (US7342118B2) will expire on August 18, 2025. Meanwhile, the polymorph patent (US10941118B2), which discloses various forms of Nirogacestat Hydrobromide polymorphs ranging from type A to type N, is due to expire on August 9, 2039. Importantly, the implementation of the polymorph patent has resulted in extending the product’s protection by approximately 14 years.

     

    Summary

    An examination of data from the last six years (as detailed in Table 4) shows that aside from 2022, the FDA has consistently approved 40 to 60 new drugs annually, with 30 to 40 of these being small molecule new drugs, and 20 to 30 being small molecule oral solid formulations. Despite various challenges faced by the pharmaceutical industry these years, there was a significant increase in the number of approved new drugs last year, reaching levels comparable to the peak observed between 2018 and 2020. It is noteworthy that in the first five years, the rate of polymorph patent applications for small molecule drugs in solid or semi-solid formulations remained steady at 60% to 70%. However, this year saw a rise to 83%, indicating a growing focus on the research of drug solid-state and the application of polymorph patents.

     

    Table 4. Summary of new drugs approved by FDA in the last 6 years


    Year

    2018

    2019

    2020

    2021

    2022

    2023

    New drugs approved by FDA

    59

    48

    53

    50

    37

    55

    Small molecule new drugs

    39

    32

    34

    31

    17

    38

    Solid/Semi-solid formulations drugs

    31

    26

    20

    23

    15

    24

    Drugs with polymorph patent application

    19

    17

    12

    16

    10

    20

    Proportion

    61%

    65%

    60%

    70%

    67%

    83%

     

    The focus on drug crystal forms and the application of polymorph patents has increasingly become a critical aspect for innovator companies in the development of new drugs. This heightened attention stems from two main factors. Firstly, the crystal forms of a drug plays a vital role in its stability, the feasibility of its process development, and its bioavailability. These aspects are crucial in the new drug development and are key considerations for regulatory authorities when approving small molecule drugs. Secondly, securing effective patent protection for drug crystal forms creates substantial technological barriers, allowing innovator companies to fend off competition from generic manufacturers. This strategy extends the market protection duration for new drugs and leads to greater economic benefits. Hence, research on drug crystal forms and strategic application of polymorph patents holds significant importance for innovator companies.

     

    For many year, Crystal Pharmatech has been extensively engaged in the polymorphic research of small molecule drug. The company offers a range of services in drug solid-state research and development, including crystal screening and developability assessment. Additionally, Crystal Pharmatech specializes in providing various services related to the application and analysis of polymorph patents, which are customized to meet diverse drug research and development requirements, as detailed in Table 5.

     

    Table 5. Services related to Polymorph patent.


    Drug development stage

    Polymorph patent strategy analysis

    Patentability assessment

    Polymorph patent application research scheme

    Polymorph patent application

    Patent reply support

    Formulation of non-infringement strategy

    Formulation of defense strategy

    Pre-Tox




    Pre-IND




    Phase I




    Phase II

    Phase III

    NDA

    Post Marketing

     

    Reference:

    [1] https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023.

    [2] https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm.

    [3] For granted patents, the official expiration date as announced is considered authoritative.

    [4] Expiration date of the polymorph patent minus the expiration date of the compound patent.


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    Amorphous Solid Dispersion (Spray Drying & Hot-melt Extrusion) Dr. LianFeng Huang Joins Crystal Pharmatech as Chief Scientist Biologics Characterization and Evaluation of Amorphous Solid Dispersion (ASD) - Part 1 Characterization and Evaluation of Amorphous Solid Dispersion-Part 2 ADME Simulations: Insights into Bioavailability and Pharmacokinetics Utilizing Compaction Simulation for Advancing Oral Dosage Formulation Design Critical Quality Attribute D0 Impact in ADC Modality SAPA Annual Conference (Gold Corporate Sponsorship) Crystal Bio Solutions Bio Analytics API Form and Solid-State Research Crystallization Development Mini-tablet Knowledge Hub Molecules-to-Medicine: Accelerating Drug Development through Collaboration PBPK in Preclinical/FIH Scenarios Case Study 4: Gatifloxacin - Crystalline Form Changes With A Licensed Compound Presentations Using Thermodynamic Phase Maps in API Crystallization Process Design Pre-clinical Formulation Strategies Sponsored by Crystal Pharmatech Date: 2:00-3:00 pm EDT, Wednesday, Whatch on-demand
    Stability and Solubility Studies Comprehensive Physicochemical Property Evaluation Pediatric Formulation (Mini-tablet) Crystal Formulation Services successfully passed the dual certification of GMP and GDP conducted by SGS Development and Production Application Cases of Amorphous Solid Dispersion Formulations (I) - Hot Melt Extrusion Unveil Key Factors Influencing the Physical Stability of Amorphous Solid Dispersions Assessment of CQA in mRNA-LNP Modality Parameter Sensitivity with GastroPlus 14th American Drug Delivery and Formulation Summit (Exhibit) Developability Assessment, Pre-formulation Study for IND Enabling Product Quality Analysis Additional Capabilities Chiral Separation Technology Our Partner Advanced Characterization: Tools for Accelerating Molecules to Medicine Tools for Accessing New Solid Forms Case Studies Case Study 5: Lifecycle Management - Olanzapine - Crystalline Change From Free Acid to Salt Amorphous Solid Dispersions Enabling Poorly Soluble Weak Bases for Improved Bioavailability: Why a Salt May Not be the Best Choice Integrated Phase and Formulation Selection to Support GLP Toxicology and First in Human Studies Sponsored by Crystal Pharmatech In-Silico PBPK Modeling and Simulation Industry Shift: FDA Goes Vegan? Date: 2:00-3:00 pm EDT, Wednesday,Watch on-demand
    Crystallization Development Services Excipient Selection and Compatibility Studies Analytical Chemistry Unlock Solubility Enhancement Methods for Poorly Soluble Oral Drugs Development and Production Application Cases of Amorphous Solid Dispersion Formulations (II) - Spray Drying Sterility Assays in Drug/Device Manufacturing Overcoming Bioavailability Barrier to Deliver Protein Degraders 2024 CASSS - Mass Spec Symposium Flow Cytometry About Us Pre-formulation Studies Formulations for PK/Efficacy/Tox Studies Crystallization and Spray Drying Process Development, Scale-Up, and Technology Transfer Case Study 6: Oxybutynin- Crystalline Change From Salt to Free Base Technical Articles Learn about Drug Eutectic Screening Crystal Pharmatech's CDMO Business Unit - Crystal Formulation Services Received China Drug Product Manufacturing License, Achieving the Important Milestone in Formulation Capability Development and Production Application Cases of Amorphous Solid Dispersion Formulations (I) - Hot Melt Extrusion Overcoming Poor Solubility and Dissolution of Insoluble Molecules Patent Analysis of Resmetirom ChemOutsourcing 2024 Crystal Bio Webinar ELISpot Assays Solid-State NMR Analysis Resources Avoiding Drug Failures: Right First Time; Fast First Time Exploring the Pharmaceutical Solid State by Molecular Simulation Crystallization Process Method SMART Development of Pre-clinical Candidates Crystal Pharmatech Recognized as "Best Partner" by Allorion Therapeutics for Excellent Services Formulation and Analytical Development Animal Dosing Vehicle Selection Understand ASD Manufacturing Strategies, Choose the Optimal One Review of Polymorph Patent Application of 30 Small Molecule New Drugs Approved by the FDA in 2023 Immuno-Oncology Summit 2024 - Meet Crystal Bio at Booth 15 Molecular Biology Clinical and Commercial Manufacturing Amorphous Solid Dispersions Careers Tools and Strategies for De-risking Rapid Drug Substance and Drug Product Development Crystal Pharmatech Returned to AAPS 2022 PharmSci 360 Fun Sharing: The Secret Behind the Silky Smoothness of Chocolate (Part 2) GMP Manufacturing Detecting Low-Level Crystallinity in ASD-like Samples Using ssNMR Techniques A Brief Introdction to Amorphous Solid Dispersion Technology FIH-PMF-FMF Manufacturing The Bioprocessing Summit 2024 - Meet Crystal Bio at Booth T13 Contact Us Crystal Pharmatech and Particle Sciences Form a US-China Pharmaceutical CRO Partnership Advancements in Analytical Tools for API and DP Characterization API Crystallization Fun Sharing: The Secret behind the Silky Smooth Enjoyment of Chocolate (Part 3) Unlock Solubility Enhancement Methods for Poorly Soluble Oral Drugs Amorphous Solid Dispersions: Two Heads Are Better Than One Meet Crystal Pharmatech at 2024 Controlled & Modified Drug Release Summit Search Result Webinar Series Crystal Pharmatech Raises $10 Million to Accelerate Growth Solid Forms: The Good; The Bad; The Ugly Co-crystals Fun Sharing: The Secret Behind the Silkiness of Chocolate (Part 1) Join Crystal Pharmatech for the Sino-American Pharmaceutical Professionals Association (SAPA) NE 26th Annual Conference Assessment of Powder Segregation in Direct Compression (DC) Blends: Developing Predictive and PAT Tools Sitemap Crystal Formulation Services, Formulation Tailor-made for Your Molecules Utility of Single Crystal in Form and Formulation Selection Impact of Solid-state in Early Development ​Crystal Pharmatech will be in San Diego from June 3-6 at BIO International Convention Formulation Design and Development of Fixed Dose Combination Solid Oral Dosage Forms 404 Candoo Enables the Successful Development of a BCS 4 Combo Drug Product Introduction to MicroED Technology and Solutions Optimal Preclinical Formulation Development Fun Sharing:The Story Between Ice Crystals and Frozen Foods (Part 3) Meet Crystal Pharmatech at Chinese Antibody Society 2024 Annual Conference Drug Delivery and Patient Centric Approaches to Drug Development  Privacy Policy International Company Crystal Pharmatech Finds CCIT An Optimal Spot for First US Location Formulation Implications Salts Meet Crystal Pharmatech at 15th Drug Discovery Strategic Summit (DDSS) Submission Successful! Crystal Pharmatech Triples Headquarters in Biobay, China, with More Floors and Labs Pharmaceutical Solid-state Forms Fun Sharing: The Relationship Between Ice Crystals and Frozen Foods (Part 1) Clinical Supply Meet Crystal Pharmatech at Sorption Symposium North America 2024 Taggg Xceleron and Crystal Pharmatech Announce Partnership to Improve Early Clinical Development Utilizing Absolute Bioavailability Trials and Solid-State Solutions CPHI North America - Meet Crystal Pharmatech at Booth 1441 Search Result Service Crystal Pharmatech Introduces Customized Service Packages for Customers Seeking Materials Science Approaches in Drug Discovery and Development Fun Sharing: The Story of Ice Crystals and Frozen Foods (Part 2) Meet Crystal Pharmatech at MIDD+ Boston 2024 Meina Liang, Ph.D. Search Result Others Crystal Pharmatech Expands Leadership Team Case Study on Development and Production Applications of Amorphous Solid Dispersions - Hot Melt Extrusion Formulation Development: Fastest-to-FIH Without Sacrificing Quality Crystal Formulation Services(CFS)Opens New Formulation Development Center and Analytical R&D Lab in Suzhou, China event page Development and Production Application Case Study of Amorphous Solid Dispersions: Spray Drying DCAT WEEK: CMC Discussions Amorphous Solid Dispersion Technology and the Service Advantages of Crystal Pharmaceutical AAPS PharmSci360 - Meet Us at Booth # 2106 Candoo's Formulation Technology Platform Featured in the Drug Development & Delivery Journal ASD Column | Mastering Stable Art: Unveiling Key Factors Influencing Physical Stability of Amorphous Solid Dispersions Meet the Crystal Pharmatech formulation team next week at CPHI Crystal Pharmatech and the Future of Pharma at AAPS PharmSci 360 Crystal Formulation Services' GMP Manufacturing Facility Successfully Passes the Remote Audit by US Client, Marking a Key Milestone for Its International Expansion ASD Column | How to Select Polymers in Hot-melt Extrusion Process? Crystal Pharmatech Raring to Go to ChemOutsourcing 2022 ASD Column | Understanding the ASD Preparation Methods and Selecting the Optimal Method for Solution Crystal Bio Welcomes Dr. Shiaw-Lin (Billy) Wu as Co-Founder and Chief Scientific Officer CPHI North america - Meet Us at Booth #530 Polymorphs, Solvatomorphs and Hydrate of Dabrafenib Crystal Bio Appoints Dr. Ye Gu as Co-founder, CTO, and Head of USA BD Shining Glory: Unveiling the "True Eye" behind the Veil of Drug Crystal Forms Crystal Pharmatech's CDMO Business Unit - Crystal Formulations Services Successfully Passed EU QP Audit Crystal Pharmatech and Divamics Announce Strategic Collaboration to Accelerate Drug Development through AI, Crystal Form, and Formulation Innovation Applications of Dynamic Moisture Adsorption in Crystal Research Meet Crystal Pharmatech at AAPS National Biotechnology Conference Application of Granularity Analysis in Crystal Typing Research Assessment of CQA in mRNA-LNP Modality DCAT Week 2025 A Brief Introduction to Amorphous Solid Dispersion Technology ADME Simulations: Insights into Bioavailability and Pharmacokinetics 19th WRIB (Workshops on Recent Issues in Bioanalysis)  Understand ASD Manufacturing Strategies, Choose the Optimal One Parameter Sensitivity with GastroPlus Review of Polymorph Patent Application of 30 Small Molecule New Drugs Approved by the FDA in 2023 Unveil Key Factors Influencing the Physical Stability of Amorphous Solid Dispersions Characterization and Evaluation of Amorphous Solid Dispersion (ASD) - Part 1 Optimizing Polymer Selection for Amorphous Solid Dispersion in Hot Melt Extrusion Processes Crystal’s Perspective: Polymorph Patent Landscape of 28 FDA-Approved Small Molecule Drugs in 2024 How to Mitigate Disproportionation of API Salts in Pharmaceutical Formulations
    Solid Form Screening Solid Form Developability Evaluation Absolute Structure Determination Crystallization Process Development The Purpose Behind Molecules to Medicine Repurposing Dexmedetomidine into an Oral Sleep-Enhancing Medication The Role of Collaboration in Optimizing the Development of HIF Inhibitors for the Treatment of Advan Mol2Med™ Integrated Services AAPS 2024 PHarmSCi 360 Concerned about mRNA -LNP Integrity during International Shipping? Improving the Manufacture of mRNA Biologics Patient-Centered Controlled and Modified Release Drug Delivery: Formulation & Process Development BIO International Convention Home Formulation Development Solid Form Screening and Selection Our Company Talent Recruitment Case Study 1: Indinavir - Early Salt Form Change The Tiny-TIM System Whitepaper Solid Form Research Engineering Cocrystal Solubility and Streamlining Cocrystal Early Development The Use of Amorphous Solid Dispersions to Enhance Dissolution, and Oral Bioavailability of Poorly Water-Soluble Pharmaceutical C Biologics CMC Analytical Services High-Resolution Mass Spectrometry Crystal Pharmatech Formulation Forum News & Events Optimizing Polymer Selection for Amorphous Solid Dispersion in Hot Melt Extrusion Processes Formulation & Delivery US 2024 Concerned about mRNA -LNP Integrity during International Shipping? Analytical Techniques to Assess the mRNA 5' Cap How to Mitigate Disproportionation of API Salts in Pharmaceutical Formulations Small Molecule Solid-State Characterization/FAST Conventional Oral Solid Dosage Forms Our History News Our Business Case Study 2: DPC 961 – Form Change On A Fast Track Compound Detecting and Avoiding Disappearing Polymorph Cases by Crystal Structure Prediction Preclinical and Tox Formulation Development Synthonic Engineering: Tools for the Rational Design of High Quality Pharmaceuticals Polymorphism of Drugs - Can We Exploit Physical Form in the Development of Low Solubility Molecules? Bioanalysis and Biomarker Services 2023-Mol2Med™ First-Time-Right Approach Webinar Series Date: 2:00-3:00 pm EDT, Wednesday, Watch on-demand
    Developability Assessment Oral Solid Dosage Forms ASD Series Development and Production Application Cases of Amorphous Solid Dispersion Formulations (II) - Spray Drying CATUG and Crystal Bio Establish Strategic Partnership, Launching “CATUG-Crystal” Joint Lab Dedicated to Advanced Nucleic Acid Analytical Services Characterization and Evaluation of Amorphous Solid Dispersion - Part 2 Critical Quality Attribute (CQA) in Antibody Drug Conjugate (ADC) Modality Unlocking the Power of AI in Pharmaceutical Development The 16th Drug Discovery Strategic Summit (DDSS) - San Francisco Bioanalytical and Biomarker Services Crystal’s Perspective: Polymorph Patent Landscape of 28 FDA-Approved Small Molecule Drugs in 2024 Single Crystal Growth & Structure Determination Bioavailability Enhancement for Insoluble Compounds & PROTAC & Oral Peptides Our People Events Case Study 3: Atorvastatin - Crystalline Form Change In Late Development Selecting the Right API Form and Formulation Instrumentation for Electron Diffraction, Applications, and Case Studies Effective Development of API Crystallization Processes During Drug Development Efficient Preclinical Formulation Development for Poorly Soluble Compounds pKa/LogP/LogD Measurements Date: 2:00-3:00 pm EDT, Wednesday, Watch on-demand
    Amorphous Solid Dispersion (Spray Drying & Hot-melt Extrusion) Dr. LianFeng Huang Joins Crystal Pharmatech as Chief Scientist Biologics Characterization and Evaluation of Amorphous Solid Dispersion (ASD) - Part 1 Characterization and Evaluation of Amorphous Solid Dispersion-Part 2 ADME Simulations: Insights into Bioavailability and Pharmacokinetics Utilizing Compaction Simulation for Advancing Oral Dosage Formulation Design Critical Quality Attribute D0 Impact in ADC Modality SAPA Annual Conference (Gold Corporate Sponsorship) Crystal Bio Solutions Bio Analytics API Form and Solid-State Research Crystallization Development Mini-tablet Knowledge Hub Molecules-to-Medicine: Accelerating Drug Development through Collaboration PBPK in Preclinical/FIH Scenarios Case Study 4: Gatifloxacin - Crystalline Form Changes With A Licensed Compound Presentations Using Thermodynamic Phase Maps in API Crystallization Process Design Pre-clinical Formulation Strategies Sponsored by Crystal Pharmatech Date: 2:00-3:00 pm EDT, Wednesday, Whatch on-demand
    Stability and Solubility Studies Comprehensive Physicochemical Property Evaluation Pediatric Formulation (Mini-tablet) Crystal Formulation Services successfully passed the dual certification of GMP and GDP conducted by SGS Development and Production Application Cases of Amorphous Solid Dispersion Formulations (I) - Hot Melt Extrusion Unveil Key Factors Influencing the Physical Stability of Amorphous Solid Dispersions Assessment of CQA in mRNA-LNP Modality Parameter Sensitivity with GastroPlus 14th American Drug Delivery and Formulation Summit (Exhibit) Developability Assessment, Pre-formulation Study for IND Enabling Product Quality Analysis Additional Capabilities Chiral Separation Technology Our Partner Advanced Characterization: Tools for Accelerating Molecules to Medicine Tools for Accessing New Solid Forms Case Studies Case Study 5: Lifecycle Management - Olanzapine - Crystalline Change From Free Acid to Salt Amorphous Solid Dispersions Enabling Poorly Soluble Weak Bases for Improved Bioavailability: Why a Salt May Not be the Best Choice Integrated Phase and Formulation Selection to Support GLP Toxicology and First in Human Studies Sponsored by Crystal Pharmatech In-Silico PBPK Modeling and Simulation Industry Shift: FDA Goes Vegan? Date: 2:00-3:00 pm EDT, Wednesday,Watch on-demand
    Crystallization Development Services Excipient Selection and Compatibility Studies Analytical Chemistry Unlock Solubility Enhancement Methods for Poorly Soluble Oral Drugs Development and Production Application Cases of Amorphous Solid Dispersion Formulations (II) - Spray Drying Sterility Assays in Drug/Device Manufacturing Overcoming Bioavailability Barrier to Deliver Protein Degraders 2024 CASSS - Mass Spec Symposium Flow Cytometry About Us Pre-formulation Studies Formulations for PK/Efficacy/Tox Studies Crystallization and Spray Drying Process Development, Scale-Up, and Technology Transfer Case Study 6: Oxybutynin- Crystalline Change From Salt to Free Base Technical Articles Learn about Drug Eutectic Screening Crystal Pharmatech's CDMO Business Unit - Crystal Formulation Services Received China Drug Product Manufacturing License, Achieving the Important Milestone in Formulation Capability Development and Production Application Cases of Amorphous Solid Dispersion Formulations (I) - Hot Melt Extrusion Overcoming Poor Solubility and Dissolution of Insoluble Molecules Patent Analysis of Resmetirom ChemOutsourcing 2024 Crystal Bio Webinar ELISpot Assays Solid-State NMR Analysis Resources Avoiding Drug Failures: Right First Time; Fast First Time Exploring the Pharmaceutical Solid State by Molecular Simulation Crystallization Process Method SMART Development of Pre-clinical Candidates Crystal Pharmatech Recognized as "Best Partner" by Allorion Therapeutics for Excellent Services Formulation and Analytical Development Animal Dosing Vehicle Selection Understand ASD Manufacturing Strategies, Choose the Optimal One Review of Polymorph Patent Application of 30 Small Molecule New Drugs Approved by the FDA in 2023 Immuno-Oncology Summit 2024 - Meet Crystal Bio at Booth 15 Molecular Biology Clinical and Commercial Manufacturing Amorphous Solid Dispersions Careers Tools and Strategies for De-risking Rapid Drug Substance and Drug Product Development Crystal Pharmatech Returned to AAPS 2022 PharmSci 360 Fun Sharing: The Secret Behind the Silky Smoothness of Chocolate (Part 2) GMP Manufacturing Detecting Low-Level Crystallinity in ASD-like Samples Using ssNMR Techniques A Brief Introdction to Amorphous Solid Dispersion Technology FIH-PMF-FMF Manufacturing The Bioprocessing Summit 2024 - Meet Crystal Bio at Booth T13 Contact Us Crystal Pharmatech and Particle Sciences Form a US-China Pharmaceutical CRO Partnership Advancements in Analytical Tools for API and DP Characterization API Crystallization Fun Sharing: The Secret behind the Silky Smooth Enjoyment of Chocolate (Part 3) Unlock Solubility Enhancement Methods for Poorly Soluble Oral Drugs Amorphous Solid Dispersions: Two Heads Are Better Than One Meet Crystal Pharmatech at 2024 Controlled & Modified Drug Release Summit Search Result Webinar Series Crystal Pharmatech Raises $10 Million to Accelerate Growth Solid Forms: The Good; The Bad; The Ugly Co-crystals Fun Sharing: The Secret Behind the Silkiness of Chocolate (Part 1) Join Crystal Pharmatech for the Sino-American Pharmaceutical Professionals Association (SAPA) NE 26th Annual Conference Assessment of Powder Segregation in Direct Compression (DC) Blends: Developing Predictive and PAT Tools Sitemap Crystal Formulation Services, Formulation Tailor-made for Your Molecules Utility of Single Crystal in Form and Formulation Selection Impact of Solid-state in Early Development ​Crystal Pharmatech will be in San Diego from June 3-6 at BIO International Convention Formulation Design and Development of Fixed Dose Combination Solid Oral Dosage Forms 404 Candoo Enables the Successful Development of a BCS 4 Combo Drug Product Introduction to MicroED Technology and Solutions Optimal Preclinical Formulation Development Fun Sharing:The Story Between Ice Crystals and Frozen Foods (Part 3) Meet Crystal Pharmatech at Chinese Antibody Society 2024 Annual Conference Drug Delivery and Patient Centric Approaches to Drug Development  Privacy Policy International Company Crystal Pharmatech Finds CCIT An Optimal Spot for First US Location Formulation Implications Salts Meet Crystal Pharmatech at 15th Drug Discovery Strategic Summit (DDSS) Submission Successful! Crystal Pharmatech Triples Headquarters in Biobay, China, with More Floors and Labs Pharmaceutical Solid-state Forms Fun Sharing: The Relationship Between Ice Crystals and Frozen Foods (Part 1) Clinical Supply Meet Crystal Pharmatech at Sorption Symposium North America 2024 Taggg Xceleron and Crystal Pharmatech Announce Partnership to Improve Early Clinical Development Utilizing Absolute Bioavailability Trials and Solid-State Solutions CPHI North America - Meet Crystal Pharmatech at Booth 1441 Search Result Service Crystal Pharmatech Introduces Customized Service Packages for Customers Seeking Materials Science Approaches in Drug Discovery and Development Fun Sharing: The Story of Ice Crystals and Frozen Foods (Part 2) Meet Crystal Pharmatech at MIDD+ Boston 2024 Meina Liang, Ph.D. Search Result Others Crystal Pharmatech Expands Leadership Team Case Study on Development and Production Applications of Amorphous Solid Dispersions - Hot Melt Extrusion Formulation Development: Fastest-to-FIH Without Sacrificing Quality Crystal Formulation Services(CFS)Opens New Formulation Development Center and Analytical R&D Lab in Suzhou, China event page Development and Production Application Case Study of Amorphous Solid Dispersions: Spray Drying DCAT WEEK: CMC Discussions Amorphous Solid Dispersion Technology and the Service Advantages of Crystal Pharmaceutical AAPS PharmSci360 - Meet Us at Booth # 2106 Candoo's Formulation Technology Platform Featured in the Drug Development & Delivery Journal ASD Column | Mastering Stable Art: Unveiling Key Factors Influencing Physical Stability of Amorphous Solid Dispersions Meet the Crystal Pharmatech formulation team next week at CPHI Crystal Pharmatech and the Future of Pharma at AAPS PharmSci 360 Crystal Formulation Services' GMP Manufacturing Facility Successfully Passes the Remote Audit by US Client, Marking a Key Milestone for Its International Expansion ASD Column | How to Select Polymers in Hot-melt Extrusion Process? Crystal Pharmatech Raring to Go to ChemOutsourcing 2022 ASD Column | Understanding the ASD Preparation Methods and Selecting the Optimal Method for Solution Crystal Bio Welcomes Dr. Shiaw-Lin (Billy) Wu as Co-Founder and Chief Scientific Officer CPHI North america - Meet Us at Booth #530 Polymorphs, Solvatomorphs and Hydrate of Dabrafenib Crystal Bio Appoints Dr. Ye Gu as Co-founder, CTO, and Head of USA BD Shining Glory: Unveiling the "True Eye" behind the Veil of Drug Crystal Forms Crystal Pharmatech's CDMO Business Unit - Crystal Formulations Services Successfully Passed EU QP Audit Crystal Pharmatech and Divamics Announce Strategic Collaboration to Accelerate Drug Development through AI, Crystal Form, and Formulation Innovation Applications of Dynamic Moisture Adsorption in Crystal Research Meet Crystal Pharmatech at AAPS National Biotechnology Conference Application of Granularity Analysis in Crystal Typing Research Assessment of CQA in mRNA-LNP Modality DCAT Week 2025 A Brief Introduction to Amorphous Solid Dispersion Technology ADME Simulations: Insights into Bioavailability and Pharmacokinetics 19th WRIB (Workshops on Recent Issues in Bioanalysis)  Understand ASD Manufacturing Strategies, Choose the Optimal One Parameter Sensitivity with GastroPlus Review of Polymorph Patent Application of 30 Small Molecule New Drugs Approved by the FDA in 2023 Unveil Key Factors Influencing the Physical Stability of Amorphous Solid Dispersions Characterization and Evaluation of Amorphous Solid Dispersion (ASD) - Part 1 Optimizing Polymer Selection for Amorphous Solid Dispersion in Hot Melt Extrusion Processes Crystal’s Perspective: Polymorph Patent Landscape of 28 FDA-Approved Small Molecule Drugs in 2024 How to Mitigate Disproportionation of API Salts in Pharmaceutical Formulations
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