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    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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    Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    Suanfarma, at the Core of a Better Life.

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    About

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across...
    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative bioph

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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades. He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF). HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file Your father, Peter J. Werth, is recognized as one of the founders of the generic pharmaceutical industry, having built ChemWerth from the ground up over four decades ago. How do you view his legacy? As you take the helm, what key lessons or principles from his leadership do you intend to carry forward? My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles. His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives. As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market. I will also strive to continue his legacy of mentorship, ensuring that our company culture remains rooted in integrity and diligence, with an unyielding focus on making safe, affordable medicines available worldwide. HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive What are your top priorities as the new president of ChemWerth? How do you plan to strengthen and expand relationships with manufacturers worldwide? My immediate priorities as the new president are twofold: to enhance the value we deliver to our customers and, to deepen our relationships with our manufacturing partners worldwide. We will further diversify our supply chain and broaden our product portfolio. Our expansion plans include upgrading equipment, and hiring additional highly skilled scientists, engineers, and GMP auditors. We will also leverage our proprietary product selection and regulatory submission processes. These processes help us get the regulatory filing right the first time, and allows us to be approved 44 percent faster than the industry average. This helps our customers gain a competitive edge in the market. In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation. We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge. HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average When ChemWerth last spoke to PharmaCompass, there was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth? Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic. These investments are already paying dividends. They help us support manufacturers producing steroids, hormones, veterinary products, and large-volume APIs, while also accelerating the development of small-molecule inhibitors and new generic APIs. We have ensured that our partners are equipped with the latest equipment and trained personnel to meet cGMP standards. By partnering with facilities in these markets, we now have access to state-of-the-art production capabilities that enable us to produce a wider range of APIs at competitive costs. The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets. This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030. HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles? ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step. Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA. Our team stays continuously updated on the evolving guidelines and protocols, which allows us to file DMFs that align with current FDA practices. We recognize that many manufacturers face challenges such as complex regulatory requirements, lengthy review cycles, and the need for precise coordination between various production stages. ChemWerth helps them overcome these hurdles by offering end-to-end regulatory support, detailed internal audits, and continuous training on cGMP and FDA requirements. Our efficiency is a critical competitive advantage. By receiving approvals 44 percent faster than the industry average, we help our customers get their products to market faster, resulting in larger market share and increased profits. HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support What is your vision for ChemWerth over the next few years? How do you plan to navigate the challenges and opportunities in the generic pharmaceutical industry? I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape. At ChemWerth, our vision for the future is rooted in both our proud legacy and our relentless drive for innovation. We will further diversify our supply chain and expand our product portfolio. We have begun leveraging our expertise to supply APIs for biosimilars and new drug applications (NDAs), while maintaining our reputation for rapid regulatory approvals. With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets. HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets 

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    https://www.pharmacompass.com/speak-pharma/our-unmatched-efficiency-and-track-record-of-faster-dmf-filings-give-our-customers-a-critical-competitive-advantage

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    12 Mar 2025
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    CDMO Activity Tracker: Axplora enhances ADC capacities, Quotient beefs up HPAPI capabilities; Evonik, EUROAPI forge deals

    CDMO Activity Tracker: Axplora enhances ADC capacities, Quotient beefs up HPAPI capabilities; Evonik, EUROAPI forge deals

    The contract development and manufacturing organization (CDMO) sector witnessed significant activity in the first quarter (Q1) of 2025, characterized by strategic investments, facility expansions, and collaborative partnerships.The quarter saw some significant deals. WuXi Biologics agreed to sell its vaccine manufacturing facility in Dundalk, Ireland, to Merck for € 500 million (US$  521 million). Quadria Capital announced the acquisition of a 10 percent stake in Aragen for US$ 100 million. This investment will help Aragen accelerate its research and development efforts.Some CDMOs, like India-based Syngene International and Belgium-based Ardena expanded their presence in the US market. Syngene completed the acquisition of its first US biologics facility that it had purchased from Emergent Manufacturing Operations Baltimore for US$ 36.5 million. And, leading nanomedicine developer Ardena purchased a drug manufacturing unit in New Jersey from Catalent.  View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Axplora expands its ADC capacities; Quotient Sciences wraps up HPAPI unit upgradeThe antibody-drug conjugate (ADC) market saw considerable investments by CDMOs. Axplora expanded its commercial payload production capabilities at its Le Mans site in France, reinforcing its position as a leading player in ADC manufacturing. This expansion is part of the France 2030 program and builds on Axplora’s track record of supplying 40 percent of the world’s marketed ADCs and 50 percent of ADCs approved by the US Food and Drug Administration (FDA).Samsung Biologics said it will support a series of LigaChem Biosciences’ ADC programs at its new dedicated ADC facility. Similarly, Cerbios-Pharma announced significant enhancements to its ADC production capabilities. Cerbios also announced the expansion of its high potency active pharmaceutical ingredients (HPAPIs) production capabilities. On March 31, Cerbios-Pharma got acquired by Healthcare Advanced Synthesis, a leading developer of APIs, HPAPIs and anticancer compounds. Both these global players are based in Switzerland. Overall, HPAPIs saw significant investments. Quotient Sciences made headlines with the successful completion of a US$ 1.4 million project designed to improve high potency handling capabilities at its Philadelphia (US) facility. The initiative focused on upgrading infrastructure and implementing advanced safety protocols to manage HPAPIs more effectively.Polfa Tarchomin achieved significant milestones in enhancing its pharmaceutical manufacturing capabilities. The company successfully completed the site acceptance test (SAT) for its vial filling and packaging line at the Center for Development and Production of Highly Potent Drugs, ensuring full functionality and compliance with good manufacturing practice (GMP) standards.Additionally, Polfa Tarchomin is installing a high-tech, high-containment robotic ONCO LINE designed for aseptic production of highly potent pharmaceutical products, including lyophilisates and liquid formulations in vials and pre-filled syringes. Developed in collaboration with leading global suppliers, this line supports multiple packaging formats and comes with advanced systems. With an annual production capacity of up to 6 million units, this line will set a new benchmark in pharmaceutical manufacturing.In a significant development for analytical testing, SK Pharmteco launched an enhanced laboratory specifically designed for HPAPIs. The new facility is in California (US).  View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Evonik expands RNA portfolio; Catalent to support Galapagos’ CAR-T therapy trialsThe success of mRNA vaccines and the growing interest in RNA therapeutics is luring CDMOs to rapidly expand their capabilities in this emerging area. Evonik, in collaboration with ST Pharm, announced plans to expand its portfolio of RNA and nucleic acid therapeutic services during Q1. The partnership enables Evonik to provide customized nucleic acids from ST Pharm alongside its portfolio of lipid and lipid nanoparticle (LNP) drug product development services.ReciBioPharm secured a grant from the Bill & Melinda Gates Foundation to advance RNA manufacturing technologies that meet FDA standards with a focus on improving access to RNA therapeutics in low- and middle-income countries.The cell and gene therapy sector also witnessed remarkable activity in Q1 2025. Catalent announced it will support Galapagos’ decentralized CAR T therapy trials for GLPG5101 for relapsed/refractory non-Hodgkin lymphoma indications.Similarly, AGC Biologics announced it will manufacture and supply lentiviral vectors for Adaptimmune’s solid tumor cell therapy initiatives. And, Genenta and AGC Biologics strengthened their cell therapy manufacturing pact through a collaboration agreement. This grants Genenta access to the exclusive GMP suite at the AGC Biologics Cell and Gene Center of Excellence in Milan, dedicated to manufacturing cell therapy products.  View CDMO Activity Tracker for Q1 2025 (Free Excel Available) EUROAPI, StrainChem join hands to develop peptides; Fermion expands flow chemistry capabilitiesEven traditional therapeutics like peptides and small molecules saw considerable investments by CDMOs. For instance, EUROAPI and StrainChem announced a collaborative venture to develop liquid phase peptides. The partnership aims to harness advanced synthesis techniques and innovative technologies for more efficient peptide manufacturing. Through this collaboration, EUROAPI and StrainChem will offer their customers a one-stop shop solution for peptides. In one of the most ambitious expansions announced this quarter, CordenPharma unveiled plans to invest over € 1 billion (US$ 1.10 billion) over the next three years in building and expanding small, medium, and large peptide manufacturing facilities across Europe and the US. That includes a new greenfield facility for peptide manufacturing in the Basel region of Switzerland, valued at over € 500 million (US$ 553 million).In obesity treatments, Viking Therapeutics agreed to pay US$ 150 million to CordenPharma for the production of its dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) agonist VK2735.In a show of confidence, Indian CDMO Neuland Labs’ board approved a ₹ 3.42 billion (approximately US$ 42 million) capital expenditure plan. The approved capex is earmarked for enhancing the company’s peptide synthesizer reactor capacity and building additional capacity to meet growing demand.In the small molecule space, Fermion announced a strategic investment to expand its flow chemistry capabilities, aiming to enhance processes and sustainability by integrating continuous flow techniques into manufacturing. This technology offers advantages in scalability, process control, and safety, positioning Fermion at the forefront of pharmaceutical innovation.Recipharm announced a major expansion of its aseptic filling capabilities, encompassing process development, pilot-scale production, and clinical supply operations. Similarly, Curia announced significant expansions to its global network of sterile fill-finish sites, aiming to enhance production capacity, streamline supply chains, and improve overall quality in sterile pharmaceutical manufacturing.  View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Our viewDuring Q1 2025, the CDMO sector continued to evolve towards higher-value and more complex services. This only underscores the crucial role CDMOs are playing in supporting growth and innovation in the pharmaceutical industry.With the Trump administration in the US triggering a global tariff war, drugmakers have no option but to reshape their supply chains. And this means more business for CDMOs that manufacture drugs in the US. In the coming quarter, we expect strong dealmaking and increased focus on innovation in the CDMO sector. 
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    10 Apr 2025
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    Pfizer ends development of weight-loss pill danuglipron
    Pfizer ends development of weight-loss pill danuglipron

    15 Apr 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-ends-development-weight-loss-pill-danuglipron-2025-04-14/

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    15 Apr 2025
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    As Pfizer bows out, CSL keeps hemophilia gene therapy hopes alive
    As Pfizer bows out, CSL keeps hemophilia gene therapy hopes alive

    12 Apr 2025

    // FIERCE PHARMA

    https://www.fiercepharma.com/pharma/pfizer-backs-out-hemophilia-gene-therapy-csl-hopes-hemgenix-here-stay

    FIERCE PHARMA
    12 Apr 2025
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    Pfizer sells San Diego R&D site for $255M
    Pfizer sells San Diego R&D site for $255M

    12 Apr 2025

    // FIERCE BIOTECH

    https://www.fiercebiotech.com/biotech/pfizer-shakes-rd-presence-san-diego-255m-site-sale-56-layoffs

    FIERCE BIOTECH
    12 Apr 2025
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    Pfizer invites shareholders to virtual 2025 Annual Meeting on April
    Pfizer invites shareholders to virtual 2025 Annual Meeting on April

    10 Apr 2025

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20250410600365/en/Pfizer-Invites-Shareholders-to-Attend-Virtual-2025-Annual-Meeting-of-Shareholders-on-April-24

    BUSINESSWIRE
    10 Apr 2025
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    GSK resolves patent lawsuit against Pfizer over RSV vaccines
    GSK resolves patent lawsuit against Pfizer over RSV vaccines

    05 Apr 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/gsk-resolves-patent-lawsuit-against-pfizer-over-rsv-vaccines-2025-04-03/

    REUTERS
    05 Apr 2025
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    Europe approves Pfizer's RSV vaccine for adults at increased risk
    Europe approves Pfizer's RSV vaccine for adults at increased risk

    02 Apr 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/european-commission-approves-pfizers-rsv-vaccine-adults-increased-risk-disease-2025-04-01/

    REUTERS
    02 Apr 2025
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    Pfizer Inc

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    Pfizer Inc

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    Pfizer Inc

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    Pfizer Inc

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    Pfizer Inc

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    Pfizer Inc

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    Hospira, Inc.

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    Pfizer Inc

    Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.

    Registration Date : 2021-11-23

    Registration Number : Number 87-29-ND

    Manufacturer Name : Pfizer Ireland Pharmaceuticals

    Manufacturer Address : Ringaskiddy API Plant Rinaskiddy Country Cork Ireland

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    02

    Alprazolam

    U.S.A
    German Wound Congress
    Not Confirmed
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    Alprazolam

    U.S.A
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    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    Registrant Name : Beatrice Korea Co., Ltd.

    Registration Date : 2021-03-16

    Registration Number : 20210316-209-J-884

    Manufacturer Name : Pharmacia & Upjohn Company

    Manufacturer Address : 7000 Portage Road, Kalamazoo, Michigan 49001, USA

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    03

    Amlodipine besilate

    U.S.A
    German Wound Congress
    Not Confirmed
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    Amlodipine besilate

    U.S.A
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    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    Registrant Name : Beatrice Korea Co., Ltd.

    Registration Date : 2011-03-15

    Registration Number : 20110315-130-H-73-14

    Manufacturer Name : Viatris Pharmaceuticals LLC

    Manufacturer Address : PO Box 628 KM 58.2 Road No. 2 Barceloneta

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    04

    Amlodipine besilate

    U.S.A
    German Wound Congress
    Not Confirmed
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    Amlodipine besilate

    U.S.A
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    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    Registrant Name : Jeil Pharmaceutical Co., Ltd.

    Registration Date : 2017-06-28

    Registration Number : 20110315-130-H-73-14(1)

    Manufacturer Name : Pfizer Pharmaceuticals LLC

    Manufacturer Address : PO Box 628 KM 58.2 Road No. 2 Barceloneta

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    05

    Amlodipine besilate

    U.S.A
    German Wound Congress
    Not Confirmed
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    Amlodipine besilate

    U.S.A
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    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    Registrant Name : Beatrice Korea Co., Ltd.

    Registration Date : 2022-10-24

    Registration Number : 20221024-130-H-403-50

    Manufacturer Name : Pfizer Asia Manufacturing Pte ...

    Manufacturer Address : 31 Tuas South Avenue 6, 637578, Singapore

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    06

    Atorvastatin calcium

    U.S.A
    German Wound Congress
    Not Confirmed
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    Atorvastatin calcium

    U.S.A
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    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    Registrant Name : HKINNOEN Co., Ltd.

    Registration Date : 2019-09-24

    Registration Number : 20110110-132-H-57-04(1)

    Manufacturer Name : Upjohn Manufacturing Ireland U...

    Manufacturer Address : Little Island, Co, Cork, T45 F627, Ireland

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    07

    Atorvastatin calcium trihydrate

    U.S.A
    German Wound Congress
    Not Confirmed
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    Atorvastatin calcium trihydrate

    U.S.A
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    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    Registrant Name : Beatrice Korea Co., Ltd.

    Registration Date : 2016-01-14

    Registration Number : 20160114-132-H-285-34

    Manufacturer Name : Pfizer Ireland Pharmaceuticals

    Manufacturer Address : Ringaskiddy API Plant, PO Box 140, Ringaskiddy, Co. Cork, Ireland

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    08

    Atorvastatin calcium trihydrate

    U.S.A
    German Wound Congress
    Not Confirmed
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    Atorvastatin calcium trihydrate

    U.S.A
    arrow
    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    Registrant Name : Beatrice Korea Co., Ltd.

    Registration Date : 2011-01-10

    Registration Number : 20110110-132-H-57-04

    Manufacturer Name : Upjohn Manufacturing Ireland U...

    Manufacturer Address : Little Island Co. Cork, T45 F627, Ireland

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    09

    Azithromycin

    U.S.A
    German Wound Congress
    Not Confirmed
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    Azithromycin

    U.S.A
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    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.

    Registration Date : 2020-10-14

    Registration Number : 20201014-191-I-595-07

    Manufacturer Name : Pfizer Asia Manufacturing Pte ...

    Manufacturer Address : 31 Tuas South Avenue 6 Singapore 637578@[erythromycin manufacturing plant ①]1401 Sh...

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    10

    Azithromycin

    U.S.A
    German Wound Congress
    Not Confirmed
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    Azithromycin

    U.S.A
    arrow
    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.

    Registration Date : 2012-12-20

    Registration Number : 20121220-191-I-73-04

    Manufacturer Name : Pfizer Pharmaceuticals LLC

    Manufacturer Address : Barceloneta, PR 00617

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    NDC API

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    01

    ALPRAZOLAM

    U.S.A
    German Wound Congress
    Not Confirmed
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    ALPRAZOLAM

    U.S.A
    arrow
    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    NDC Package Code : 0009-5144

    Start Marketing Date : 2014-07-03

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    02

    ALPROSTADIL

    U.S.A
    German Wound Congress
    Not Confirmed
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    ALPROSTADIL

    U.S.A
    arrow
    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    NDC Package Code : 0009-0042

    Start Marketing Date : 2015-08-26

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    03

    AMLODIPINE BESYLATE

    U.S.A
    German Wound Congress
    Not Confirmed
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    AMLODIPINE BESYLATE

    U.S.A
    arrow
    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    NDC Package Code : 68724-0008

    Start Marketing Date : 2020-06-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    04

    ANIDULAFUNGIN

    U.S.A
    German Wound Congress
    Not Confirmed
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    ANIDULAFUNGIN

    U.S.A
    arrow
    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    NDC Package Code : 0009-0043

    Start Marketing Date : 2015-08-26

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    05

    ATORVASTATIN CALCIUM TRIHYDRATE

    U.S.A
    German Wound Congress
    Not Confirmed
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    ATORVASTATIN CALCIUM TRIHYDRATE

    U.S.A
    arrow
    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    NDC Package Code : 61947-0002

    Start Marketing Date : 2011-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    06

    AZITHROMYCIN DIHYDRATE

    U.S.A
    German Wound Congress
    Not Confirmed
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    AZITHROMYCIN DIHYDRATE

    U.S.A
    arrow
    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    NDC Package Code : 68724-2124

    Start Marketing Date : 2014-07-03

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    07

    AZITHROMYCIN, UNSPECIFIED FORM

    U.S.A
    German Wound Congress
    Not Confirmed
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    AZITHROMYCIN, UNSPECIFIED FORM

    U.S.A
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    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    NDC Package Code : 60715-3150

    Start Marketing Date : 2011-12-29

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    08

    AZTREONAM

    U.S.A
    German Wound Congress
    Not Confirmed
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    AZTREONAM

    U.S.A
    arrow
    German Wound Congress
    Not Confirmed
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    Hospira, Inc.

    NDC Package Code : 54087-160

    Start Marketing Date : 2012-01-04

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER, FOR SOLUTION (75mg/1)

    Marketing Category : DRUG FOR FURTHER PROCESSING

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    09

    BELIMUMAB

    U.S.A
    German Wound Congress
    Not Confirmed
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    BELIMUMAB

    U.S.A
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    German Wound Congress
    Not Confirmed
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    Hospira, Inc.

    NDC Package Code : 0409-9966

    Start Marketing Date : 2014-03-10

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (400mg/5mL)

    Marketing Category : DRUG FOR FURTHER PROCESSING

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    10

    CELECOXIB

    U.S.A
    German Wound Congress
    Not Confirmed
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    CELECOXIB

    U.S.A
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    German Wound Congress
    Not Confirmed
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    Pfizer Inc

    NDC Package Code : 68724-1004

    Start Marketing Date : 1998-10-02

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    FDA

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    01

    FDA Audited

    USA
    German Wound Congress
    Not Confirmed
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    FDA Audited

    USA
    arrow
    German Wound Congress
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-07-27

    Wyeth Pharmaceuticals Inc

    City : Rouses Point

    State : NY

    Country/Area : US

    Zip : 12979-1424

    District : NYK

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-07-27

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    02

    FDA Audited

    USA
    German Wound Congress
    Not Confirmed
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    FDA Audited

    USA
    arrow
    German Wound Congress
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-04-20

    Wyeth Pharmaceuticals Inc

    City : Catania

    State :

    Country/Area : IT

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-04-20

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    03

    FDA Audited

    USA
    German Wound Congress
    Not Confirmed
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    FDA Audited

    USA
    arrow
    German Wound Congress
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-03-17

    Hospira, Inc.

    City : Paravada

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-03-17

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    04

    FDA Audited

    USA
    German Wound Congress
    Not Confirmed
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    FDA Audited

    USA
    arrow
    German Wound Congress
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2016-10-25

    Wyeth Pharmaceuticals Inc

    City : Guayama

    State : PR

    Country/Area : US

    Zip : 00784

    District : SJN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2016-10-25

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    05

    FDA Audited

    USA
    German Wound Congress
    Not Confirmed
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    FDA Audited

    USA
    arrow
    German Wound Congress
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2016-09-30

    Wyeth Pharmaceuticals Inc

    City : Andover

    State : MA

    Country/Area : US

    Zip : 01810-5901

    District : NWE

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2016-09-30

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    06

    FDA Audited

    USA
    German Wound Congress
    Not Confirmed
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    FDA Audited

    USA
    arrow
    German Wound Congress
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2016-08-18

    Wyeth Pharmaceuticals Inc

    City : Sanford

    State : NC

    Country/Area : US

    Zip : 27330-9550

    District : ATL

    Center : CBER

    Project Area : Vaccines and Allergenic Products

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2016-08-18

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    07

    FDA Audited

    USA
    German Wound Congress
    Not Confirmed
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    FDA Audited

    USA
    arrow
    German Wound Congress
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2016-07-14

    Hospira, Inc.

    City : Lake Forest

    State : IL

    Country/Area : US

    Zip : 60045-2579

    District : CHI

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : No Action Indicated

    Inspection End Date : 2016-07-14

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    08

    FDA Audited

    USA
    German Wound Congress
    Not Confirmed
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    FDA Audited

    USA
    arrow
    German Wound Congress
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2016-05-26

    Hospira, Inc.

    City : Rocky Mount

    State : NC

    Country/Area : US

    Zip : 27804-8612

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2016-05-26

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    09

    FDA Audited

    USA
    German Wound Congress
    Not Confirmed
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    FDA Audited

    USA
    arrow
    German Wound Congress
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-09-24

    Hospira, Inc.

    City : Rocky Mount

    State : NC

    Country/Area : US

    Zip : 27804-8612

    District : ATL

    Center : CDRH

    Project Area : Postmarket Assurance: Devices

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-09-24

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    10

    FDA Audited

    USA
    German Wound Congress
    Not Confirmed
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    FDA Audited

    USA
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    German Wound Congress
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-09-24

    Hospira, Inc.

    City : Rocky Mount

    State : NC

    Country/Area : US

    Zip : 27804-8612

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-09-24

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    EDQM

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    01

    GMP Certified

    EU
    German Wound Congress
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    GMP Certified

    EU
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    German Wound Congress
    Not Confirmed

    Wyeth Pharmaceuticals Inc

    Type : GMP Certificates

    Number : UK GMP 1197...

    EudraGMDP Key : 11829

    Country : U.S.A

    Issue Date :

    Post Code : 12979

    NCA Ref : 23238-WYETH ...

    City : ROUSES POINT

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    02

    GMP Certified

    EU
    German Wound Congress
    Not Confirmed
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    GMP Certified

    EU
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    German Wound Congress
    Not Confirmed

    Wyeth Pharmaceuticals Inc

    Type : GMP Certificates

    Number : UK GMP 6595...

    EudraGMDP Key : 11470

    Country : U.S.A

    Issue Date :

    Post Code : 00987-4904

    NCA Ref : 17261-WYETH ...

    City : CAROLINA

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    03

    GMP Certified

    EU
    German Wound Congress
    Not Confirmed
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    GMP Certified

    EU
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    German Wound Congress
    Not Confirmed

    Wyeth Pharmaceuticals Inc

    Type : GMP Certificates

    Number : UK GMP 1197...

    EudraGMDP Key : 7518

    Country : U.S.A

    Issue Date :

    Post Code : 1810

    NCA Ref : 1006687-WYET...

    City : ANDOVER

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    04

    GMP Certified

    EU
    German Wound Congress
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    GMP Certified

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    Wyeth Pharmaceuticals Inc

    Type : GMP Certificates

    Number : ES/011/USA

    EudraGMDP Key : 12076

    Country : U.S.A

    Issue Date :

    Post Code : MA02140

    NCA Ref : 1.2076133915...

    City : Cambridge

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    Hospira, Inc.

    Type : GMP Certificates

    Number : UK GMP 2465...

    EudraGMDP Key : 8475

    Country : U.S.A

    Issue Date :

    Post Code : 27520

    NCA Ref : 91992-HOSPIR...

    City : CLAYTON

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    Wyeth Pharmaceuticals Inc

    Type : GMP Certificates

    Number : UK GMP 1749...

    EudraGMDP Key : 11918

    Country : U.S.A

    Issue Date :

    Post Code : 10965

    NCA Ref : 9559-WYETH L...

    City : PEARL RIVER

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    Hospira, Inc.

    Type : GMP Certificates

    Number : ES/015/USA

    EudraGMDP Key : 14605

    Country : U.S.A

    Issue Date :

    Post Code : 67460

    NCA Ref : 1.460513515e...

    City : McPherson

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    Hospira, Inc.

    Type : GMP Certificates

    Number : Hospira, In...

    EudraGMDP Key : 6180

    Country : U.S.A

    Issue Date :

    Post Code : 78728

    NCA Ref : 6.1801226934...

    City : Austin, Texas

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    Wyeth Pharmaceuticals Inc

    Type : GMP Certificates

    Number : UK GMP 1197...

    EudraGMDP Key : 11829

    Country : U.S.A

    Issue Date :

    Post Code : 12979

    NCA Ref : 23238-WYETH ...

    City : ROUSES POINT

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    Hospira, Inc.

    Type : GMP Certificates

    Number : Hospira, In...

    EudraGMDP Key : 6180

    Country : U.S.A

    Issue Date :

    Post Code : 78728

    NCA Ref : 6.1801226934...

    City : Austin, Texas

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    WHO-GMP

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    WHO GMP Certified

    Switzerland
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    Pfizer Inc

    Name and address of WHO GMP certified Manufacturer : Ws Pfizer Ltd., Verna Ind. Estate, Verna, Salcete-Goa 403 722

    Country : U.S.A

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    Hospira, Inc.

    Name and address of WHO GMP certified Manufacturer : ZYDUS HOSPIRA ONCOLOGY PVT. LTD MATODA -382 213

    Country : U.S.A

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    Hospira, Inc.

    Name and address of WHO GMP certified Manufacturer : HOSPIRA HEALTHCARE INDIA PVT LTD. L - 8, M.I.D.C., INDUSTRIAL AREA, WALUJ AURANGABAD AURANGABAD 431136

    Country : U.S.A

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    Hospira, Inc.

    Name and address of WHO GMP certified Manufacturer : HOSPIRA HEALTHCARE INDIA PVT LTD. PLOT NO. L - 9, M.I.D.C., INDUSTRIAL AREA, WALUJ AURANGABAD 431136

    Country : U.S.A

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    Hospira, Inc.

    Name and address of WHO GMP certified Manufacturer : M/s. Hospira Healthcare (India) Pvt.Ltd.,Plot No. B3 – B4, B11- B14, B 21-B23 & B31 – B33, Sipcot Industrial Park, Irungattukottai, Kancheepuram District – 602 105

    Country : U.S.A

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    GDUFA

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    01

    GDUFA fees paid

    USA
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    GDUFA fees paid

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    Paid in : 2019

    Hospira, Inc.

    API Manufacturer :

    FDF Manufacturer :

    Facility Name : Avara Liscate Pharmaceutical S...

    Business Address : Via Fosse Ardeatine 2 Liscat...

    FEI Number : 3004640070

    Country : U.S.A

    Paid in : 2019

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    Paid in : 2019

    Hospira, Inc.

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Hospira Australia Pty Ltd

    Business Address : 1-39 Lexia Pl Mulgrave Victo...

    FEI Number : 3001174929

    Country : U.S.A

    Paid in : 2019

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    Hospira, Inc.

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Hospira, Inc.

    Business Address : 1776 North Centennial Drive ...

    FEI Number : 1925262

    Country : U.S.A

    Paid in : 2019

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    Hospira, Inc.

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Hospira, Inc.

    Business Address : Highway 301 North Rocky Moun...

    FEI Number : 1021343

    Country : U.S.A

    Paid in : 2019

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    Paid in : 2019

    Hospira, Inc.

    API Manufacturer :

    FDF Manufacturer :

    Facility Name : ICU Medical Fleet Services, LL...

    Business Address : 3900 Howard Ln Austin TX 787...

    FEI Number : 1628454

    Country : U.S.A

    Paid in : 2019

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    06

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    Paid in : 2019

    Pfizer Inc

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : King Pharmaceuticals

    Business Address : 1200 Parkdale Road Rochester...

    FEI Number : 1876582

    Country : U.S.A

    Paid in : 2019

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    07

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    Hospira, Inc.

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Pfizer Healthcare India Privat...

    Business Address : SIPCOT Industrial Park, B3, ...

    FEI Number : 3008386908

    Country : U.S.A

    Paid in : 2019

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    Paid in : 2019

    Hospira, Inc.

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Pfizer Healthcare India Privat...

    Business Address : Plot No. 116, 117, 118, 119,...

    FEI Number : 3008316085

    Country : U.S.A

    Paid in : 2019

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    Hospira, Inc.

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Pfizer Healthcare India Privat...

    Business Address : L-8 (Part), L-9 & Gut No. 38...

    FEI Number : 3003983454

    Country : U.S.A

    Paid in : 2019

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    Pfizer Inc

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Pfizer Pharmaceuticals LLC

    Business Address : KM 1.9 Road 689 Vega Baja PR...

    FEI Number : 2623619

    Country : U.S.A

    Paid in : 2019

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    ABOUT THIS PAGE

    Contact Pfizer Inc and get a quotation

    Pfizer Inc is a supplier offers 270 products (APIs, Excipients or Intermediates).

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