Pfizer CentreOne DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

Expert Statement: Tom Wilson, Pfizer

02 Sep 2024

// CHEMANAGER

Contract Pharma Talks with Rick Knight of Pfizer CentreOne

30 Aug 2024

// CONTRACT PHARMA

Celebrating Excellence: Pfizer CentreOne wins the CDMO Leadership Awards 2024

01 Apr 2024

// PRESS RELEASE

DATA COMPILATION
#PharmaFlow

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DIGITAL CONTENT

1 INTERVIEW #SpeakPharma, 16 CORPORATE CONTENT #SupplierSpotlight, 2 COMPANY BIO #AboutSupplier, 2 DATA COMPILATION #PharmaFlow, 93 NEWS #PharmaBuzz

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1 INTERVIEW #SpeakPharma
16 CORPORATE CONTENT #SupplierSpotlight
2 COMPANY BIO #AboutSupplier
2 DATA COMPILATION #PharmaFlow
93 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

29 All APIs, 19 USDMF, 11 CEP/COS, 3 JDMF, 8 NDC API, 24 Listed APIs

29 All APIs
19 USDMF
11 CEP/COS
3 JDMF
8 NDC API
24 Listed APIs

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

8 All Intermediates

8 All Intermediates

KEY PRODUCTS

Dexamethasone, Dexamethasone Sodium Phosphate, Hydrocortisone, Hydrocortisone (Cortisol), Hydrocortisone Acetate, Hydrocortisone Butyrate, Hydrocortisone Sodium Succinate, Hydrocortisone Valerate, Medroxyprogesterone Acetate, Megestrol Acetate, Progesterone

Dexamethasone
Dexamethasone Sodium Phosphate
Hydrocortisone
Hydrocortisone (Cortisol)
Hydrocortisone Acetate
Hydrocortisone Butyrate
Hydrocortisone Sodium Succinate
Hydrocortisone Valerate
Medroxyprogesterone Acetate
Megestrol Acetate
Progesterone

SERVICES

API Manufacturing, Drug Product Manufacturing, API & Drug Product Development, Packaging

pharmaServices
API Manufacturing
Drug Product Manufacturing
API & Drug Product Development
- 8 API Development
- 11 Formulation Development
Packaging
- 9 Contract Services

KEY SERVICES

API Clinical & Commercial Supply

API Clinical & Commercial Supply

INSPECTIONS & REGISTRATIONS

146 FDA, 111 EDQM, 1 GDUFA

inspections
146 FDA
111 EDQM
1 GDUFA

Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.

About

Pfizer CentreOne® is an altogether different global contract development and manufacturing organization (CDMO), and a leading supplier of specialty APIs and intermediates.

Backed by Pfizer resources, we’ve been delivering technical expertise, regulatory support and long-term supply for over 40 years. With 35+ sites across six continents, our expansive network allows us to securely and efficiently guide complex compounds from development through commercial manufacture.

For more information, visit http://www.pfizercentreone.com

CPHI Middle eastCPHI Middle east

Industry Trade Show

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10-12 December, 2024

Riyadh Exhibition & Convention Center
Medlab Asia & Asia Hea...Medlab Asia & Asia Health

Industry Trade Show

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24 November-17 July, 2025

Malaysia Trade & Exhibition Centre
Health 2.0 ConferenceHealth 2.0 Conference

Industry Trade Show

Not Confirmed

02-04 December, 2024

Dubai, UAE

CONTACT DETAILS

Click the arrow to open the dropdown

Country

U.S.A

Address

Corporate Headquarters: 235 E. 42nd Street, New York, NY 10017

Telephone

+1 2698332296

enquiries@pharmacompass.com

Website

https://www.pfizercentreone.com/api-finder

https://www.linkedin.com/showcase/pfizer-centreone/

YouTube

http://www.youtube.com/@PfizerCentreOne

Events

Webinars & Exhibitions

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CPHI Middle east

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Industry Trade Show

Not Confirmed

10-12 December, 2024

Riyadh Exhibition & Convention Center
Medlab Asia & Asia Hea...Medlab Asia & Asia Health

Industry Trade Show

Not Confirmed

24 November-17 July, 2025

Malaysia Trade & Exhibition Centre
Health 2.0 ConferenceHealth 2.0 Conference

Industry Trade Show

Not Confirmed

02-04 December, 2024

Dubai, UAE

Digital content

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INTERVIEW #SpeakPharma

“Pfizer CentreOne is distinct from other CDMOs due to the fact that we are embedded within Pfizer”

This week, SpeakPharma interviews Pfizer CentreOne’s Andrew Moore, General Manager, and Andrew Anderson, Lead, APIs and Intermediates, who talk about Pfizer CentreOne’s CDMO services, trends impacting the CDMO industry and their leading position as a supplier of specialty APIs and intermediates to pharma companies. The company, which was created five years back, when Pfizer CentreSource and Hospira One 2 One came together, has been growing at a healthy pace of 9 percent year-on-year, and wishes to launch 25 blockbusters by 2025. It’s been over five years since Pfizer CentreSource and Hospira One 2 One came together to create Pfizer CentreOne. Can you tell us what the journey has been like? Andrew Moore: Pfizer CentreOne has been successfully guiding customers’ products from development to commercial manufacture for over 40 years. We are a global provider of contract development and manufacturing services for small molecule APIs, large molecule biologics, oral solids and sterile injectables. In collaboration with our customers, we deliver these medicines to millions of patients all over the world. Our global team consists of around 70 colleagues who bring a wealth of scientific, manufacturing, and commercial expertise. Our network includes over 35 Pfizer sites across six continents with expertise to deliver technical guidance, regulatory support, and reliable supply. Since 2015, we have worked rigorously to optimize the structure and operating model of Pfizer CentreOne. In 2019, Pfizer’s CentreOne delivered US$ 810 million in annual revenue with 9 percent growth year-on-year. We are a strong commercial entity poised to show solid financial results in 2020 as well. Andrew Anderson: In addition to this, Pfizer CentreOne is a leading supplier of specialty APIs and intermediates. Our Kalamazoo, Michigan facility, is a center of excellence for API production and continues to lead the industry by investing in next-generation processes. Customers can access the same technical and manufacturing resources that Pfizer uses for its own branded medicines. They can count on Pfizer CentreOne to deliver reliable API supply of the highest quality and a trusting partnership built on transparent communication and timelines. This is more important than ever as the industry faces increasing supply chain vulnerabilities and API supply issues. What differentiates Pfizer CentreOne from other CDMOs? Andrew Moore: Without any doubt, I can say that Pfizer CentreOne is distinct from other CDMOs due to the fact that we are embedded within Pfizer. With over 170 years of experience, Pfizer has hundreds of products to its name, and its development, manufacturing, regulatory and commercial expertise is unrivaled. When customers partner with us, they benefit from Pfizer’s specialized expertise in core therapeutic areas, enabling them to get their products to patients in a more timely and efficient manner. We believe relationships and collaboration are key for mutual success. We recognize our partners’ patients as our own and our goal is to understand their needs. Pfizer’s legacy of bringing innovative products to market is not just our history, it’s our future. We wish to launch 25 blockbusters by 2025. Pfizer invests US$ 1 billion annually into its manufacturing network and operations and this sustained commitment to innovation and optimization positions Pfizer CentreOne as a highly competitive, technology leading CDMO. The final differentiating factor is our aspiration to be the partner of choice and our customer experience promise. Our goal is to be known not only for what and when we deliver, but also for how we deliver. What are the growth areas for Pfizer CentreOne? Tell us about the geographical spread of your clients? Andrew Moore: We are focused on growing our core technology platforms through offering end-to-end solutions that start with early stage clinical development and clinical manufacturing and grow into commercial production and lifecycle management. The earlier we can influence formulation and synthesis routes the more successful our customers’ products will be, which is always our first objective. We have a great reputation for our work from Phase II through approval and we believe now is the time to offer customers the benefit of our experience in earlier development phases. In terms of geographical expansion, we are focusing on growing our presence in Asia through our state-of-the-art biotechnology manufacturing site in Hangzhou. Andrew Anderson: We also see a real opportunity to expand our API and intermediates customer base as the need for reliable API suppliers is greater than ever. Pfizer has a track record of delivering high quality API supply when customers need it most. As we have complete control over Pfizer’s own API supply from farm to factory, we are able to offer this reassurance to our customers. Can you share details on Pfizer CentreOne’s new green-chemistry API manufacturing program? Andrew Anderson: The team in our largest manufacturing facility, located in Kalamazoo, Michigan, USA, developed Enviero progesterone, the first compound to be launched from Pfizer CentreOne’s green-chemistry program. The API is produced by a first-of-its-kind progesterone synthesis process that reduces waste, greenhouse gas emissions and the use of hazardous solvents. Developed during the last decade, this represents a step change in progesterone API synthesis. Manufactured via a proprietary biocatalytic process based on plant sterols, efficiency and sustainability results have been exceptional, including cutting the carbon footprint of the progesterone manufacturing process by more than 70 percent and eliminating the use of metal catalysts. What are some of the trends impacting CDMOs? What are some of the areas where Pfizer CentreOne will be investing in the coming years? Andrew Moore: We believe that there has never been a more dynamic market nor a greater role for pharma and commercial partners. As more companies, including small, mid-sized and large pharma, turn to CDMOs for bringing their products to market, the CDMO industry is vital to advancing pharma breakthroughs. This has influenced CDMOs to invest in acquisitions and alliances to stay ahead of pharma’s development curve. Despite the increasing dependency of the pharmaceutical industry on CDMOs, the classic needs for CDMO partners remain as before — scientific innovation, high-demand technical experience, and first-class capabilities. Customers appreciate CDMO partners who present quality systems that prevent excursions and warnings along with a proven commercial track record. Emerging industry needs are demanding more agility and a culture of continuous improvement, with responsive infrastructure to permit flexible scale profiles — particularly important with high complexity oral solid dosages. Pfizer CentreOne will continue to focus on playing a strategic role in the successful development and commercial manufacture of our customers’ products and on optimizing our delivery through digital technology and infrastructure investments. Guiding today’s drug strategies through close collaboration with our customers will enable us to overcome some of today’s and tomorrow’s toughest drug development challenges.

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