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    Company profile for PolyPeptide Group

    Suanfarma, at the Core of a Better Life.

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    Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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    Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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    Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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    Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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    EVENTS

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    About

    PolyPeptide is a Contract Development & Manufacturing Organization (CDMO) focusing on proprietary and generic GMP-grade peptides used by pharmaceutical and biotech companies in approved pharmaceutical products, drugs in clinical development as well as in generic products. Dating back to 1952, PolyPeptide today manufactures around one half of all currently approved peptide drug substances with a global footprint of six GMP-cert...
    PolyPeptide is a Contract Development & Manufacturing Organization (CDMO) focusing on proprietary and generic GMP-grade peptides used by pharmaceutical and biotech companies in approved pharmaceutical products, drugs in clinical development as well as in generic products. Dating back to 1952, PolyPeptide today manufactures around one half of all currently approved peptide drug substances with a global footprint of six GMP-certified facilities in Europe, the U.S. and India. As a multinational company with more than 1000 employees, its diversity brings breadth, depth of knowledge and experience to the group.

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    CONTACT DETAILS

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    PolyPeptide GroupSwitzerland Flag
    Country
    Country
    Switzerland
    Address
    Address
    Dammstrasse 19 6300 Zug Switzerland
    Telephone
    Telephone
    +41 (0) 41 723 20 40
    Client Email
    Email
    enquiries@pharmacompass.com
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    Website
    https://www.polypeptide.com/
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

    Impressions: 4926

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    https://www.pharmacompass.com/speak-pharma/translational-pharmaceutics-our-flagship-platform-for-drug-development-empowers-our-clients-with-unparalleled-flexibility

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    16 Dec 2024
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    VLOG #PharmaReel

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

    BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

    Since 2022, there has been a significant surge in layoffs by pharmaceutical and biotech companies. While this trend continued into 2024, the industry showed signs of stabilization in the last four months of the year with the pace of layoffs slowing down. Nonetheless, 2024 was a challenging year. Data compiled by PharmaCompass indicates that over 25,000 layoffs were announced in 2024, driven by economic pressures, failed clinical trials, and strategic pivots. Bristol Myers Squibb and Johnson & Johnson led the layoffs with about 2,300 job cuts each. Bayer announced elimination of 1,800 positions.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) US, Europe, China bear brunt of job cuts; Big Pharma hands pink slips to 10,000 Over 190 biopharma companies announced layoffs in 2024. The year began on a grim note — 27 firms announced significant job cuts in January 2024. By the yearend, Big Pharma alone had contributed more than 10,000 layoffs to the year’s total of over 25,000. Novartis announced over 1,200 job cuts in 2024. It eliminated 330 jobs after it acquired German biotech MorphoSys through the closure of sites in Munich and Boston. Similarly, Bayer announced significant reductions at its US and Swiss facilities.  North America saw increased retrenchments, especially at biotech hubs such as Boston, San Diego, and New Jersey. Massachusetts, with Boston and Cambridge as the epicenter of US biotechnology, saw around 4,000 layoffs, with companies like Relay Therapeutics, Editas Medicine, and Takeda driving the numbers. In San Diego, workforce reductions by Takeda, and Bavarian Nordic collectively resulted in over 900 job losses, significantly impacting the local biotech ecosystem. New Jersey was subject to broader restructuring efforts with BMS and Bayer contributing nearly 1,500 layoffs. The impact in Europe was equally severe. Germany, home to some of the world’s largest pharmaceutical companies, saw over 2,500 layoffs as Bayer and Boehringer Ingelheim scaled back operations. Novartis’ decision to shut down its Munich site added hundreds more to the tally. In Switzerland, Idorsia eliminated 270 positions. Dutch biotech UniQure reduced its workforce by 65 percent (around 300 jobs). That included the sale of a Massachusetts manufacturing facility to Genezen. Denmark also felt the strain, with Leo Pharma cutting 250 roles as part of a strategic revamp. China emerged as another focal point of workforce reductions in 2024. Global pharmaceutical giants, such as Merck and Johnson & Johnson, restructured their operations in response to market complexities in the region. Local companies such as Connect Biopharma, which is transitioning to a US-focused company, also scaled back their presence in the country.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Amylyx, FibroGen, Lyra, Athira drastically reduce staff over setbacks in clinical trials Clinical trial failures were one of the most significant drivers of layoffs in 2024. For instance, Amylyx Pharmaceuticals faced a devastating blow when its amyotrophic lateral sclerosis (ALS) therapy, Relyvrio, failed a confirmatory trial. This led to a 70 percent reduction in its workforce, leaving only 100 employees from the 384 full-time staff reported at the end of 2023. The company’s decision to pull the therapy from the market compounded the layoffs. BioMarin Pharmaceutical had to reduce its workforce, as it streamlined its pipeline in response to trial challenges. In August, the company announced a reduction of 225 employees, citing “organizational redesign efforts”. These layoffs followed 170 redundancies announced earlier in May. FibroGen, once considered a leader in oncology drug development, was among the most heavily impacted. The high-profile failure of its anti-CTGF antibody in two late-stage cancer trials led to the discontinuation of its lead candidate, resulting in a 75 percent reduction in its US workforce. Lyra Therapeutics also implemented a 75 percent workforce reduction, affecting 87 employees, after its chronic rhinosinusitis program struggled. Similarly, Athira Pharma cut 70 percent of its team after its Alzheimer’s candidate failed a phase 2/3 trial.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Cash crunch, mergers compel Kronos Bio, Editas, Vincerx, Gilead to downsize In addition to clinical failures, funding constraints played a pivotal role in reshaping the biotech landscape. Kronos Bio stood out as one of the hardest-hit firms, cutting 21 percent and 83 percent of its existing workforce in March and November, respectively, as it sought to divest assets and conserve cash. Editas Medicine’s inability to secure partnerships for its sickle cell program forced the company to revert to preclinical research, resulting in a 65 percent workforce reduction. The trend of scaling back R&D pipelines was particularly evident among biotechs struggling to advance preclinical programs to clinical trials. Boundless Bio and Senti Bio exemplified this, choosing to focus on a handful of promising candidates, while reducing discovery efforts. Consolidation often results in overlapping roles, leading to inevitable workforce reductions. Apart from the MorphoSys layoffs by Novartis, Vincerx Pharma faced job losses after it got acquired by Oqory (a clinical-stage ADC company). Vincerx had to cut its workforce by 55 percent.  Amid ongoing reorganization efforts, Gilead closed its Seattle, Washington (US), office and laid off 72 employees of its subsidiary Kite Pharma. Gilead also announced that its Kite facility in Philadelphia, Pennsylvania (US), would close by mid-2025. That was followed by 104 additional layoffs at its California headquarters. In April, it had cut 58 jobs in California. Gilead also announced that its Kite facility in Philadelphia would close by mid-2025. Vir Biotechnology reduced its workforce by 25 percent (i.e. 140 layoffs) to focus on its hepatitis program, and GlycoMimetics let go of 80 percent of its workforce after the FDA demanded an additional clinical trial for its leukemia treatment. Meanwhile, Lexicon Pharmaceuticals reduced its workforce by 60 percent after it stopped commercial operations and transitioned back to being a clinical stage company.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Our view It takes decades to build innovation ecosystems. The concentration of layoffs in major biotech hubs has raised concerns about the potential long-term impact on these ecosystems. In 2025, the key challenge will be to maintain the momentum of innovation, as organizations operate with a leaner workforce and a more focused pipeline.  
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    Impressions: 4652

    https://www.pharmacompass.com/radio-compass-blog/bms-j-j-bayer-lead-25-000-pharma-layoffs-in-2024-amylyx-fibrogen-kronos-bio-hit-by-trial-failures-cash-crunch

    #PharmaFlow by PHARMACOMPASS
    16 Jan 2025
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    NEWS #PharmaBuzz

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    PolyPeptide Group Partners with Novavax on COVID-19 Vaccine
    PolyPeptide Group Partners with Novavax on COVID-19 Vaccine

    04 Jun 2020

    // CONTRACTPHARMA

    https://www.contractpharma.com/contents/view_breaking-news/2020-06-04/polypeptide-group-partners-with-novavax-on-covid-19-vaccine/

    CONTRACTPHARMA
    04 Jun 2020
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    Polypeptide Therapeutic Solutions and PMC Isochem sign business and technology collaboration agreement in the field of Cosmetic and Therapeutic Polypeptide.
    Polypeptide Therapeutic Solutions and PMC Isochem sign business and technology collaboration agreement in the field of Cosmetic and Therapeutic Polypeptide.

    12 Mar 2018

    // PRESS RELEASE

    http://pmcisochem.fr/sites/default/files/Polypeptide%20Therapeutic%20Solutions%20and%20PMC%20Isochem%20%20press%20release%20March%2012%202018%20NM.pdf

    PRESS RELEASE
    12 Mar 2018
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    Lonza sells peptide biz, Recipharm adds Indian ops
    Lonza sells peptide biz, Recipharm adds Indian ops

    05 Jan 2017

    // Dan Stanton IN PHARMATECHNOLOGIST

    http://www.in-pharmatechnologist.com/Ingredients/Lonza-sells-peptide-biz-Recipharm-adds-Kemwell-s-Indian-ops

    Dan Stanton IN PHARMATECHNOLOGIST
    05 Jan 2017
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    Lonza to Sell Therapeutic Peptides Business to PolyPeptide
    Lonza to Sell Therapeutic Peptides Business to PolyPeptide

    08 Dec 2016

    // G MacDonald IN PHARMATECHNOLOGISTS

    http://www.in-pharmatechnologist.com/Ingredients/Lonza-to-sell-therapeutic-peptides-business-to-PolyPeptide

    G MacDonald IN PHARMATECHNOLOGISTS
    08 Dec 2016
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    ALL APIs

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    01

    Leuprolide Acetate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
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    Leuprolide Acetate

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13150

    Submission : 1998-08-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-321 - Rev 02

    Issue Date : 2023-01-26

    Type : Chemical

    Substance Number : 1442

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 231MF10082

    Registrant's Address : Ho(¨)gerudsgatan 21, Limhamn

    Initial Date of Registration : 2019-04-03

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2020-01-28

    Valid Till : 2022-06-27

    Written Confirmation Number : WC-0047a3

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59149-002

    Start Marketing Date : 2023-04-03

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (100g/100g)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Daewoong Pharmaceutical Co., Ltd.

    Registration Date : 2019-04-15

    Registration Number : 20170725-210-J-1(A)

    Manufacturer Name : PolyPeptide Laboratories Pvt. Ltd.

    Manufacturer Address : Plot No K28, Additional MIDC, Anandnagar Ambernath(E) Thane 421506 Maharashtra state, India

     VMF Others AUDIT
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    02

    Desmopressin Acetate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Desmopressin Acetate

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 8396

    Submission : 1990-01-26

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2006-266 - Rev 00

    Issue Date : 2013-11-27

    Type : Chemical and TSE

    Substance Number : 712

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10047

    Registrant's Address : Ho(¨)gerudsgatan 21, Limhamn

    Initial Date of Registration : 2024-03-27

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 63586-0005

    Start Marketing Date : 1982-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Meditip Co., Ltd.

    Registration Date : 2022-03-08

    Registration Number : 20220308-209-J-1247

    Manufacturer Name : PolyPeptide Laboratories (Sweden) AB

    Manufacturer Address : Högerudsgatan 21, Limhamn, 216 13, Sweden

     VMF Others AUDIT
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    03

    Desmopressin Acetate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Desmopressin Acetate

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16813

    Submission : 2003-09-03

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2000-142 - Rev 04

    Issue Date : 2010-02-12

    Type : Chemical and TSE

    Substance Number : 712

    Status : Valid

     JDMF arrow-down
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    Registration Number : 224MF10122

    Registrant's Address : Ho(¨)gerudsgatan 21, Limhamn

    Initial Date of Registration : 2012-07-09

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 63586-0005

    Start Marketing Date : 1982-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Meditip Co., Ltd.

    Registration Date : 2022-03-08

    Registration Number : 20220308-209-J-1247

    Manufacturer Name : PolyPeptide Laboratories (Sweden) AB

    Manufacturer Address : Högerudsgatan 21, Limhamn, 216 13, Sweden

     VMF Others AUDIT
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    04

    Exenatide

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
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    Exenatide

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19646

    Submission : 2006-07-31

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 223MF10041

    Registrant's Address : Chausse(')e de Tubize 297, Braine-L'Alleud, 1420, Belgium

    Initial Date of Registration : 2011-03-10

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2020-01-28

    Valid Till : 2022-06-27

    Written Confirmation Number : WC-0047a3

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59149-004

    Start Marketing Date : 2023-02-20

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (250g/250g)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Meditip Co., Ltd.

    Registration Date : 2022-04-28

    Registration Number : Su233-2-ND

    Manufacturer Name : PolyPeptide Laboratories Pvt. Ltd.

    Manufacturer Address : Plot No K28, Additional MIDC, Anandnagar Ambernath(E) Thane 421506 Maharashtra state, India

     VMF Others AUDIT
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    05

    Octreotide Acetate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Octreotide Acetate

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14994

    Submission : 2000-08-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-279 - Rev 00

    Issue Date : 2022-04-29

    Type : Chemical

    Substance Number : 2414

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-06-27

    Valid Till : 2022-06-26

    Written Confirmation Number : WC-0047

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59149-007

    Start Marketing Date : 2023-02-20

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (6g/6g)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Meditip Co., Ltd.

    Registration Date : 2022-07-11

    Registration Number : 20220711-210-J-1331

    Manufacturer Name : PolyPeptide Laboratories Pvt. Ltd

    Manufacturer Address : Plot No. K28, Addtional MIDC, Anandnagar, Ambernath(E), Thane 421 506, Maharashtra State, India

     VMF Others AUDIT
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    06

    Felypressin

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Felypressin

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-247 - Rev 01

    Issue Date : 2018-11-05

    Type : Chemical

    Substance Number : 1634

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 220MF10039

    Registrant's Address : Ho(¨)gerudsgatan 21, Limhamn

    Initial Date of Registration : 2008-02-05

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 63586-0123

    Start Marketing Date : 2018-09-14

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (0.2g/.2g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

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    Market
    Place

    07

    Leuprolide Acetate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Leuprolide Acetate

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-03-31

    Pay. Date : 2013-02-28

    DMF Number : 26832

    Submission : 2013-02-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-045 - Rev 00

    Issue Date : 2009-02-13

    Type : Chemical

    Substance Number : 1442

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 59149-002

    Start Marketing Date : 2023-04-03

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (100g/100g)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Daewoong Pharmaceutical Co., Ltd.

    Registration Date : 2019-04-15

    Registration Number : 20170725-210-J-1(A)

    Manufacturer Name : PolyPeptide Laboratories Pvt. Ltd.

    Manufacturer Address : Plot No K28, Additional MIDC, Anandnagar Ambernath(E) Thane 421506 Maharashtra state, India

     VMF Others AUDIT
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    08

    Teriparatide Acetate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Teriparatide Acetate

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-07-29

    Pay. Date : 2015-04-01

    DMF Number : 22322

    Submission : 2008-12-16

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 230MF10022

    Registrant's Address : 365 Maple Avenue, Torrance, CA 90503, U.S. S. A

    Initial Date of Registration : 2018-02-14

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    09

    Calcitonin

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Calcitonin

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12775

    Submission : 1997-12-02

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1997-091 - Rev 03

    Issue Date : 2022-02-07

    Type : Chemical

    Substance Number : 471

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 63586-0002

    Start Marketing Date : 2011-12-16

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (20g/20g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Place

    10

    Corticotropin

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Corticotropin

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIO Partnering at JPM
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21473

    Submission : 2008-03-28

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2020-01-28

    Valid Till : 2022-06-27

    Written Confirmation Number : WC-0047a3

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 59149-005

    Start Marketing Date : 2023-04-11

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (350g/350g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    USDMF

    read-more
    read-more

    01

    Acyline

    U.S.A
    PharmaVenue
    Not Confirmed
    arrow

    02

    Alpha-corticotropin (1-24) Acetate

    Switzerland
    PharmaVenue
    Not Confirmed
    arrow

    03

    Antocin

    Switzerland
    PharmaVenue
    Not Confirmed
    arrow

    04

    Bivalirudin (tm-001-2g)

    Switzerland
    PharmaVenue
    Not Confirmed
    arrow

    05

    Calcitonin (salmon)

    Switzerland
    PharmaVenue
    Not Confirmed
    arrow

    06

    Calcitonin (salmon), Ph.eur.

    Switzerland
    PharmaVenue
    Not Confirmed
    arrow

    07

    Deslorelin Acetate

    Switzerland
    PharmaVenue
    Not Confirmed
    arrow

    08

    Desmopressin

    Switzerland
    PharmaVenue
    Not Confirmed
    arrow

    09

    Desmopressin (acetate) (code Sf278)

    Switzerland
    PharmaVenue
    Not Confirmed
    arrow

    10

    Desmopressin Acetate Drug Substance

    Switzerland
    PharmaVenue
    Not Confirmed
    arrow
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    KDMF

    read-more
    read-more

    01

    Acetate terliprepressin

    U.S.A
    PharmaVenue
    Not Confirmed
    arrow

    Acetate terliprepressin

    U.S.A
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    NEOMPS INC

    Registrant Name : Jaytech Biogen

    Registration Date : 2005-09-15

    Registration Number : 20050915-59-A-112-02

    Manufacturer Name : NeoMPS, Inc.

    Manufacturer Address : 9395 Cabot Drive, San Diego, CA 92121, USA

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    Market
    Place

    02

    Atosiban

    Switzerland
    PharmaVenue
    Not Confirmed
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    Atosiban

    Switzerland
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    PolyPeptide Group

    Registrant Name : Dongkook Pharmaceutical Co., Ltd.

    Registration Date : 2015-03-30

    Registration Number : 20121121-192-I-106-01(1)

    Manufacturer Name : PolyPeptide Laboratories (Swed...

    Manufacturer Address : Hogerudsgatan 21 SE-216 13 Limhamn, Sweden

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    Market
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    03

    Atosiban

    Switzerland
    PharmaVenue
    Not Confirmed
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    Atosiban

    Switzerland
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    PolyPeptide Group

    Registrant Name : Korea Ferring Pharmaceutical Co., Ltd.

    Registration Date : 2012-11-21

    Registration Number : 20121121-192-I-106-01

    Manufacturer Name : PolyPeptide Laboratories (Swed...

    Manufacturer Address : Hogerudsgatan 21 SE-216 13 Limhamn

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    04

    Atosiban

    Switzerland
    PharmaVenue
    Not Confirmed
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    Atosiban

    Switzerland
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    PolyPeptide Group

    Registrant Name : Hanlim Pharmaceutical Co., Ltd.

    Registration Date : 2015-09-09

    Registration Number : 20121121-192-I-106-01(2)

    Manufacturer Name : PolyPeptide Laboratories (Swed...

    Manufacturer Address : Hogerudsgatan 21 SE-216 13 Limhamn

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    05

    Degarelix

    Switzerland
    PharmaVenue
    Not Confirmed
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    Degarelix

    Switzerland
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    PolyPeptide Group

    Registrant Name : Korea Ferring Pharmaceutical Co., Ltd.

    Registration Date : 2013-03-18

    Registration Number : Su3127-1-ND

    Manufacturer Name : PolyPeptide Laboratories (Swed...

    Manufacturer Address : Hogerudsgatan 21 SE-216 13 Limhamn

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    Market
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    06

    Desmopressin acetate

    Switzerland
    PharmaVenue
    Not Confirmed
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    Desmopressin acetate

    Switzerland
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    PolyPeptide Group

    Registrant Name : Meditip Co., Ltd.

    Registration Date : 2022-03-08

    Registration Number : 20220308-209-J-1247

    Manufacturer Name : PolyPeptide Laboratories (Swed...

    Manufacturer Address : Högerudsgatan 21, Limhamn, 216 13, Sweden

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    07

    Desmopressin acetate

    Switzerland
    PharmaVenue
    Not Confirmed
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    Desmopressin acetate

    Switzerland
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    PolyPeptide Group

    Registrant Name : Korea Ferring Pharmaceutical Co., Ltd.

    Registration Date : 2022-01-05

    Registration Number : 20220105-209-J-1192

    Manufacturer Name : PolyPeptide Laboratories (Swed...

    Manufacturer Address : Högerudsgatan 21, Limhamn, 216 13, Sweden

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    08

    Exenatide

    Switzerland
    PharmaVenue
    Not Confirmed
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    Exenatide

    Switzerland
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    PolyPeptide Group

    Registrant Name : Meditip Co., Ltd.

    Registration Date : 2022-04-28

    Registration Number : Su233-2-ND

    Manufacturer Name : PolyPeptide Laboratories Pvt. ...

    Manufacturer Address : Plot No K28, Additional MIDC, Anandnagar Ambernath(E) Thane 421506 Maharashtra state,...

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    Market
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    09

    Leuprorelin acetate

    Switzerland
    PharmaVenue
    Not Confirmed
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    Leuprorelin acetate

    Switzerland
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    PolyPeptide Group

    Registrant Name : Peptron Co., Ltd.

    Registration Date : 2017-07-25

    Registration Number : 20170725-210-J-1

    Manufacturer Name : PolyPeptide Laboratories Pvt. ...

    Manufacturer Address : Plot No K28, Additional MIDC, Anandnagar Ambernath(E) Thane 421506 Maharashtra state,...

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    Market
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    10

    Leuprorelin acetate

    Switzerland
    PharmaVenue
    Not Confirmed
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    Leuprorelin acetate

    Switzerland
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    PolyPeptide Group

    Registrant Name : BC World Pharmaceutical Co., Ltd.

    Registration Date : 2017-12-08

    Registration Number : 20170725-210-J-1(1)

    Manufacturer Name : PolyPeptide Laboratories Pvt. ...

    Manufacturer Address : Plot No K28, Additional MIDC, Anandnagar Ambernath(E) Thane 421506 Maharashtra state,...

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    Services

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    API Manufacturing

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    API & Drug Product Development

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    Inspections and registrations

    Upload your audits for free, ask us

    FDA

    read-more
    read-more

    01

    FDA Audited

    USA
    Duphat
    Not Confirmed
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    FDA Audited

    USA
    arrow
    Duphat
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2009-03-27

    PolyPeptide Group

    City : Torrance

    State : CA

    Country/Area : US

    Zip : 90503-2602

    District : LOS

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2009-03-27

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    #PharmaFlow

    02

    FDA Audited

    USA
    Duphat
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Duphat
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2009-03-27

    PolyPeptide Group

    City : Torrance

    State : CA

    Country/Area : US

    Zip : 90503-2602

    District : LOS

    Center : CVM

    Project Area : Monitoring of Marketed Animal Dr...

    District Decision : No Action Indicated

    Inspection End Date : 2009-03-27

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    03

    FDA Audited

    USA
    Duphat
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Duphat
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2010-01-13

    PolyPeptide Group

    City : Torrance

    State : CA

    Country/Area : US

    Zip : 90503-2602

    District : LOS

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2010-01-13

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    04

    FDA Audited

    USA
    Duphat
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Duphat
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2011-07-07

    PolyPeptide Group

    City : Torrance

    State : CA

    Country/Area : US

    Zip : 90503-2602

    District : LOS

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2011-07-07

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    05

    FDA Audited

    USA
    Duphat
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Duphat
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2011-07-07

    PolyPeptide Group

    City : Torrance

    State : CA

    Country/Area : US

    Zip : 90503-2602

    District : LOS

    Center : CVM

    Project Area : Monitoring of Marketed Animal Dr...

    District Decision : No Action Indicated

    Inspection End Date : 2011-07-07

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    06

    FDA Audited

    USA
    Duphat
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Duphat
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-02-22

    PolyPeptide Group

    City : Torrance

    State : CA

    Country/Area : US

    Zip : 90503-2602

    District : LOS

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-02-22

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    07

    FDA Audited

    USA
    Duphat
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Duphat
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2013-04-12

    PolyPeptide Group

    City : Torrance

    State : CA

    Country/Area : US

    Zip : 90503-2602

    District : LOS

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2013-04-12

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    08

    FDA Audited

    USA
    Duphat
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Duphat
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2013-04-12

    PolyPeptide Group

    City : Torrance

    State : CA

    Country/Area : US

    Zip : 90503-2602

    District : LOS

    Center : CVM

    Project Area : Monitoring of Marketed Animal Dr...

    District Decision : No Action Indicated

    Inspection End Date : 2013-04-12

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    09

    FDA Audited

    USA
    Duphat
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Duphat
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2009-09-16

    PolyPeptide Group

    City : Strasbourg

    State :

    Country/Area : FR

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2009-09-16

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    10

    FDA Audited

    USA
    Duphat
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Duphat
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2009-10-07

    PolyPeptide Group

    City : Limhamn

    State :

    Country/Area : SE

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2009-10-07

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    ABOUT THIS PAGE

    Contact PolyPeptide Group and get a quotation

    PolyPeptide Group is a supplier offers 41 products (APIs, Excipients or Intermediates).

    Find a price of Leuprolide Acetate bulk with DMF, CEP, JDMF offered by PolyPeptide Group

    Find a price of Desmopressin Acetate bulk with DMF, CEP, JDMF offered by PolyPeptide Group

    Find a price of Exenatide bulk with DMF, JDMF offered by PolyPeptide Group

    Find a price of Octreotide Acetate bulk with DMF, CEP offered by PolyPeptide Group

    Find a price of Felypressin bulk with CEP, JDMF offered by PolyPeptide Group

    Find a price of Leuprolide Acetate bulk with DMF, CEP offered by PolyPeptide Group

    Find a price of Teriparatide Acetate bulk with DMF, JDMF offered by PolyPeptide Group

    Find a price of Calcitonin bulk with CEP offered by PolyPeptide Group

    Find a price of Corticotropin bulk with DMF offered by PolyPeptide Group

    Find a price of Desmopressin Acetate bulk with DMF offered by PolyPeptide Group

    Find a price of Somatostatin bulk with CEP offered by PolyPeptide Group

    Find a price of Terlipressin Acetate bulk with CEP offered by PolyPeptide Group

    Find a price of Arginine Vasopressin bulk with DMF offered by PolyPeptide Group

    Find a price of Bivalirudin bulk with DMF offered by PolyPeptide Group

    Find a price of Calcitonin bulk with DMF offered by PolyPeptide Group

    Find a price of Deslorelin bulk with DMF offered by PolyPeptide Group

    Find a price of Difelikefalin bulk with JDMF offered by PolyPeptide Group

    Find a price of Eptifibatide bulk with DMF offered by PolyPeptide Group

    Find a price of Exenatide bulk with DMF offered by PolyPeptide Group

    Find a price of Glepaglutide bulk with DMF offered by PolyPeptide Group

    Find a price of Gonadorelin Acetate bulk with JDMF offered by PolyPeptide Group

    Find a price of Linaclotide bulk with DMF offered by PolyPeptide Group

    Find a price of Liraglutide bulk with DMF offered by PolyPeptide Group

    Find a price of Octreotide Acetate bulk with DMF offered by PolyPeptide Group

    Find a price of Pramlintide bulk with DMF offered by PolyPeptide Group

    Find a price of Secretin bulk with DMF offered by PolyPeptide Group

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