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

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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
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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

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

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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.

Impressions: 4577

CORPORATE CONTENT #SupplierSpotlight

Product List 2022

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GMP Certificate 2024

OSD Campaign Assets Brochure

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Sterile Injectables Brochure

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Large Molecule Biologics

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Sterile Injectables Development Services

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Small Molecule APIs Brochure

Oral Solids Brochure

Ascoli Site Brochure

Newbridge Site Brochure

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Kalamazoo Site Brochure

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Freiburg Site Brochure

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Enviero ™ Progesterone

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General Capabilities Brochure

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PC1's Expertise in Gene & Cell Therapy

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DATA COMPILATION #PharmaFlow

CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines.

Impressions: 3041

FDA approves record eight biosimilars in H1 2024; okays first interchangeable biosimilars for Eylea

Biologics, or complex drugs that are derived from living organisms, have revolutionized treatment of various conditions such as cancer, autoimmune diseases, and chronic illnesses. In 2023, eight out of 10 of the world’s top-selling drugs were biologics, including Merck’s Keytruda, AbbVie’s Humira, and Sanofi’s Dupixent.Due to their high costs, accessibility of biologics has been a challenge. That’s why biosimilars, or game-changing copycats of biologics that provide highly similar yet more affordable alternatives to established biologics, are becoming popular.The first biosimilar — Sandoz’ Zarxio — was approved by the US Food and Drug Administration (FDA) in 2015. Its reference biologic was Amgen’s Neupogen (filgrastim). Since then, the global market for biosimilars has been growing at an impressive pace — between 2015 and 2020, it grew at a whopping compounded annual growth rate (CAGR) of 78 percent, touching US$ 17.9 billion in size. It is expected to continue growing at a CAGR of 15 percent and reach a size of about US$ 75 billion by 2030.Major biosimilar players include Amgen, Sandoz, Samsung Bioepis, Pfizer, Biocon Biologics, Celltrion, Stada Arzneimittel, Accord Healthcare, Fresenius Kabi, Coherus Biosciences, Apotex, and Sanofi. The increasing demand for biosimilars has propelled growth in contract manufacturing. Some of the leading contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) that manufacture biosimilars are Polpharma Biologics, Catalent, Pfizer CentreOne, Lonza, Boehringer Ingelheim BioXcellence, Thermo Fisher Scientific, WuXi Biologics, and FUJIFILM Diosynth Biotechnologies.Access the Interactive Dashboard for Biosimilar Developments (Free Excel)Amgen, Sandoz top list of ‘approved biosimilars’; FDA okays 8 copycats in H1 2024Over the recent years, regulatory agencies like the FDA and the European Medicines Agency (EMA) have established rigorous approval pathways for biosimilars.Since 2015, FDA has approved 53 biosimilars, while the EMA has approved 86 biosimilars. Among the US, European and Canadian markets, Amgen and Sandoz are tied in the first place with 13 approved biosimilars each. Samsung Biologics has nine approved biosimilars, followed by Pfizer with eight and Biocon Biologics with seven. In the first half of this year, FDA set a record by approving eight biosimilars — the highest for H1 of any year. EMA has okayed six biosimilars so far in 2024.In 2023, five biosimilars were approved by the FDA with just one being okayed in the first half. The year marked the end of exclusivity for Humira after 20 years, in which it netted a total of US$ 200 billion in sales. AbbVie’s flagship autoimmune drug has a record 10 biosimilars.Johnson & Johnson’s Stelara also lost exclusivity in 2023 and as many as 11 drugmakers hope to bring its biosimilars to the market. Amgen’s Wezlana was the first biosimilar to Stelara, and it was approved as interchangeable by FDA in October last year.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) FDA approves first interchangeable biosimilar for Eylea, cuts regulatory feeDeveloping a biosimilar costs both money and time. According to Pfizer, developing a biosimilar can take five to nine years and cost over US$ 100 million, not including regulatory fees.In October 2023, FDA slashed its fees with the program fee at US$ 177,397, down from US$ 304,162. The application fees for products that require clinical data has been set at US$ 1,018,753, down from US$ 1,746,745. The application fee for products that don’t require clinical data has been set lower — at US$ 509,377 — down from US$ 873,373 set earlier. This reduction in application fee has propelled demand for contract manufacturing of biosimilars.There has also been a rise in approvals of interchangeable biosimilars this year. Interchangeable biosimilars meet additional requirements and may be substituted for its reference product by a pharmacist without consulting the prescriber. This year saw FDA approve the first interchangeable biosimilars for bone cancer drug denosumab (Prolia and Xgeva) in Jubbonti and Wyost as well as for eculizumab (Soliris) in Bkemv.In May, FDA approved the first interchangeable biosimilars for eye drug aflibercept (Eylea) in Opuviz and Yesafili. Other biosimilars approved in 2024 include Simlandi for adalimumab (Humira), Tyenne for tocilizumab (Actemra), Selarsdi for ustekinumab (Stelara), and Hercessi for trastuzumab (Herceptin).Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Merck’s Keytruda, BMS’ Opdivo, Novartis’ Cosentyx brace for biosimilar competitionHealthcare spending in the US is projected to rise from US$ 4.5 trillion in 2022 to US$ 6 trillion by 2027. While biologics involve just two percent of prescriptions, they account for 46 percent of all pharmaceutical spending. In 2022, US$ 252 billion was spent on biologics.Biosimilar-related savings in 2023 were estimated to be US$ 9.4 billion in the US and € 10 billion (US$ 10.68 billion) in Europe. With expensive and widely used drugs like AbbVie’s Humira, J&J’s Stelara, and Regeneron’s Eylea coming under competition, US savings are projected to reach US$ 181 billion through 2027. Between 2026 and 2032, about 39 blockbusters are set to lose exclusivity in the US and Europe. Merck’s Keytruda (pembrolizumab) was the world’s top-selling drug last year, generating US$ 25 billion in sales. Its patent is set to expire in 2028 with sales expected to drop 19 percent to US$ 27.4 billion in 2029 from US$ 33.7 billion the previous year. Samsung Bioepis and Amgen initiated phase 3 trials of pembrolizumab in April and May of this year, respectively.Opdivo (nivolumab), belonging to the same class of drugs, competes with Keytruda and is also set to lose patent protection in 2028. It hauled in US$ 10 billion in total global sales in 2023 for Bristol Myers Squibb. The key patents of Novartis’ Cosentyx (secukinumab) are set to expire between 2025 and 2026. Cosentyx saw sales of US$ 5 billion in 2023. Taizhou Mabtech Pharmaceutical and Bio-Thera Solutions are conducting phase 3 trials of secukinumab.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Our viewWith over 2 billion people worldwide unable to access life-saving medicines, biosimilars hold the key to healthcare accessibility. In 2023, a record 13 biosimilars were launched in the market — the highest for a single year. And this included nine much-anticipated biosimilars to AbbVie’s Humira. In April this year, FDA announced a Biosimilars Action Plan to streamline the development of biosimilars. With a sharp focus on biosimilars, we expect more records to be broken in the near term. New launches of biosimilars to drugs like J&J’s Stelara, Regeneron’s Eylea and Merck’s Keytruda will surely help in creating new records.

Impressions: 2406

COMPANY BIO #AboutSupplier

View Pfizer CentreOne's portfolio of APIs & intermediate products & also view Pfizer CentreOne's CDMO / CMO services on PharmaCompass.

View Pfizer CentreOne's portfolio of APIs & intermediate products & also view Pfizer CentreOne's CDMO / CMO services on PharmaCompass. Q1. What is Pfizer CentreOne and what services does it offer? Pfizer CentreOne is a global CDMO embedded within Pfizer and it’s a leading supplier of specialty APIs (Active Pharmaceutical Ingredients). Backed by Pfizer resources, they deliver technical expertise, global regulatory support and long-term supply. For more than 40 years, Pfizer CentreOne has been guiding complex compounds (e.g. antibiotics, complex steroids and hormones, etc.) securely and efficiently from development through to commercialization. Pfizer CentreOne also provides contract development and manufacturing for small molecule APIs, large molecule biologics, oral solids and sterile injectables, along with being a leading supplier of specialty APIs and intermediates.? Consequently, their key services are divided into the following categories: 1. Development Pfizer CentreOne offers development services for drug substances (small molecule APIs and large molecule biologics) and drug products (oral solid doses and sterile injectables). Some of these development services are noted below. - Formulation Development - Process Development - Clinical manufacturing - API Development - Safety screening - API synthesis - Scale-up (including API scale-up) - Regulatory support Manufacturing Pfizer CentreOne also offers manufacturing services for drug substances (small molecule APIs and large molecule biologics) and drug products (oral solid doses and sterile injectables). Some of these manufacturing services are noted below. - Lyophilization - Micronization - Complex organic synthesis - Microbial fermentation - Compression - API manufacturing APIs and Intermediates Pfizer CentreOne offers both API development services (e.g. API scale-up, process development, etc.) and API manufacturing services (e.g. API synthesis, complex organic synthesis, etc.). It makes some of the most difficult-to-produce complex steroids and hormones, prostaglandins, and antibiotics. Furthermore, Pfizer CentreOne has been a leading provider of specialty APIs for more than 50 years. They bring quality, integrity, technical expertise and supply assurance, and seek to continuously improve your products. Some key products in Pfizer CentreOne’s API and intermediate portfolio are noted below. - Dexamethasone - Hydrocortisone - Progesterone - Testosterone Q2. Where are some of Pfizer CentreOne’s manufacturing sites located and what is their regulatory inspection history? Pfizer, with more than 170 years of experience and hundreds of products to its name, continues to invest more than $1B annually into its manufacturing sites. Their global manufacturing network includes more than 35 sites across six continents. From these facilities, they deliver technical expertise (e.g. complex organic synthesis, API scale-up, etc.), global regulatory support and reliable supply to customers across the world. Pfizer CentreOne’s Facility Highlights: - Freiburg, Germany The site in Freiburg, Germany manufactures about 4.5B tablets and capsules annually, supporting millions of patients all over the world. Freiburg offers expertise in oral solid process and product development, flexible volume manufacturing, leading packaging technologies, and global delivery. With decades of worldwide experience and regulatory approvals for all markets including U.S., China and Japan, Freiburg is well equipped to meet all global aggregation and serialization requirements. - Kalamazoo, Michigan The largest manufacturing site in the Pfizer network is in Kalamazoo, Michigan, with facilities spanning a total area of 90 acres. Kalamazoo has a long legacy of innovation, industrial safety, and regulatory compliance, as well as an industry leading sustainability program, and produces approximately 1 million kg of API (Active Pharmaceutical Ingredient) and 10 million kg of intermediates every year. The Kalamazoo site is inspected on an ongoing basis by regulatory authorities from around the globe and is committed to patient safety and product quality at every step in the manufacturing and supply chain process. From 2015 to 2020, Pfizer CentreOne’s Kalamazoo site has received numerous regulatory inspections from major regulatory bodies such as FDA (USA), EMA (Europe), ANVISA (Brazil), etc. - Newbridge, Kildare, Ireland The manufacturing site in Newbridge, Ireland offers specialized expertise in complex oral solids and capabilities ranging from pilot to commercial scale manufacturing (commercialization). Newbridge has over 25 years of experience in contract manufacturing and supplying medicines to patients around the globe. The site is 800-colleague strong, with 10,000+ years of collective expertise. Pfizer CentreOne’s Newbridge site has received 25 regulatory inspections in the past 10 years from USFDA, HPRA (Irelend), Argentina, Korea, etc. and has a track record of zero critical observations. Furthermore it has been certified by the Health Products Regulatory Authority and received regulatory approvals from the FDA (US) and ANMAT (Argentina). - Ascoli, Italy The manufacturing site in Ascoli, Italy offers high quality pharmaceutical manufacturing in oral solids with specialization in highly potent medicines and high complexity management. Ascoli offers end-to-end CDMO services from product and process development for lab and pilot scale to full manufacturing at commercial scale (commercialization). It receives regulatory inspections from major regulatory bodies such as FDA (USA), ANVISA (Brazil), AIFA (Italy), Turkey, Russia, and MFDS Korea and the site's commitment to quality is evident by their regulatory record, with zero critical observations throughout the history of the site. - Hangzhou, China Pfizer Hangzhou Global Biotechnology Center is part of Pfizer’s Global Biotech Operating Unit and offers CDMO services for drug substance, drug product and sterile injectables. The Hangzhou site leverages Pfizer’s global experience in bio products, including mAbs. It was designed to meet international as well as CFDA cGMP requirements. Q3. What are the environmental sustainability initiatives taken by Pfizer CentreOne? Pfizer CentreOne is committed to high standards of Environmental, Health and Safety (EHS) performance. Embedded within Pfizer, Pfizer CentreOne aims to follow and achieve the objectives set out in Pfizer’s EHS policy. This policy is implemented through a comprehensive EHS Management System and overseen by governance arrangements that involve everyone within Pfizer CentreOne. Performance is monitored and regularly reviewed to ensure that the standards meet Pfizer’s expectations, and that the EHS Policy continues to be of value to business, customers and patients. Furthermore, they have a long-standing commitment to protecting the environment and the communities in which they operate, including a commitment to all 17 of the U.N. Sustainable Development Goals. Pfizer CentreOne continues to find ways to minimize its impact on the environment during the manufacturing of pharmaceuticals. Some environmental sustainability initiatives taken by Pfizer CentreOne: - All of Pfizer CentreOne’s facilities quantify water use, report performance against reduction targets, and support community efforts during drought conditions. They follow the framework under the U.N. Global Compact Water Mandate to guide their Water Sustainability Program. - Pfizer CentreOne is dedicated to collaborating across their supply chain to reduce the environmental footprint of packaging. They leverage innovative packaging materials, designs and systems that minimize impact on the environment, provide benefits to patients and reduce costs. - At Pfizer CentreOne’s Kalamazoo manufacturing site in Michigan, USA, they’ve implemented projects that have annually reduced greenhouse gas emissions by 24,000 metric tons and hazardous waste disposal volume by 10 million kilograms. - At their Puurs facility in Belgium, the online wind turbines have reduced CO2 emissions by 13,000 tons per year, with onsite renewable energy sources providing more than half of Puurs’ electrical needs. - Environmental sustainability initiatives include managing waste in a responsible manner. Pfizer CentreOne takes a multi-faceted approach by focusing on source reduction, waste minimization, and recycling improvements. Typically, this is done at both the site and regional level by establishing targets to reduce the generation of solid waste and reuse solvents through recovery processes. - Pfizer CentreOne’s green chemistry program has launched its first compound, Enviero (en-VI-ro) progesterone, which led to more than a 70% reduction in their carbon footprint as compared to the traditional progesterone production process they previously used. Furthermore, no metal catalysts were used. - Pfizer CentreOne supports and undertakes environmental projects that restore land, preserve wildlife, and help conserve natural resources. - Pfizer CentreOne leverages its Green Chemistry and Biotechnology program to advance scientific innovation to help develop processes that are more sustainable, environmentally sound and cost-effective. Q4. What are some of the new technologies offered by Pfizer CentreOne? Pfizer CentreOne sells APIs and intermediates manufactured in the U.S. under Pfizer’s quality standards and their API and intermediate capabilities encompass complex steroids and hormones, antibiotics, and prostaglandins. Pfizer CentreOne uses various new technologies. Some of these new technologies for intermediate and API development and manufacturing (API synthesis) and the production of other pharmaceuticals are noted below. - Continuous Manufacturing Technology (CMT) These innovative, next generation technologies allow for continuous processing and greater flexibility for partners. CMT has proven to increase efficiency and quality of production. The process is made possible by a proprietary Pfizer technology called continuous mixing. With the technology, a specially designed mixing unit can blend active ingredients into a homogeneous compound without interruption. The process saves time and money, and reduces the possibility for error. - High Containment (HighCon) Manufacturing The latest addition to Pfizer’s Freiburg site is a high containment facility due to open in 2021. Implementing latest technology in automated dispensing and weighing processes, the facility expands the site’s high containment offer in OEB 4/5 and provides the level of expertise and capacity required to respond to partner challenges in highly potent oral solids. Analytical capabilities include real-time release and NIR process analytical technology for blending and content uniformity. The facility equipment meets industry 4.0 standards and is certified for energy efficiency and sustainability through Leadership in Energy and Environmental Design (LEED) program. - Portable Continuous Miniature and Modular (PCMM) Manufacturing PCMM comprises a network that integrates a small footprint, continuous processing equipment, smart control systems and PODs (portable, self-contained GMP modules) to process API (Active Pharmaceutical Ingredient) powders and inactive ingredients into bulk tablets. Materials arrive to production through a fully automated feeding system; this and the Pfizer developed mixing technology ensure high homogeneity and uniformity. New measuring methods constantly check the quality during ongoing production in real time. This self-contained and fully automated process allows Freiburg to further increase production flexibility and accelerate scale-up. - Osmotic Drug Product Technology In 2021 Pfizer CentreOne’s Newbridge facility will become equipped with osmotic drug product technology which will enable solvent membrane coating, laser drilling, aqueous film coating, printing, bead solvent coating, bead solvent coating, active (hormonal and non hormonal) coating, sugar and film coating, and encapsulation. - Hi-tech Packaging Machine In August 2020, Pfizer CentreOne’s Ascoli site installed a new hi-tech machine for one of their packaging lines. The robotic machine, created by their engineering and manufacturing department in collaboration with a local supplier, reaches new heights of performance assuring high quality and safety standards. Q5. What are Pfizer CentreOne’s revenues? 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. Pfizer CentreOne falls within the Pfizer Biopharmaceuticals Group, a science based medicines business that includes six business units - Oncology, Inflammation and Immunology, Rare Disease, Hospitals, Vaccines and Internal Medicine. More specifically Pfizer CentreOne falls under the Hospital unit of the Pfizer Biopharmaceuticals Group. The Hospital unit which includes Pfizer’s contract manufacturing operation, Pfizer CentreOne, commercializes Pfizer’s global portfolio of sterile injectable and anti-infective medicines. As per Pfizer’s 2019 financial reports, Pfizer CentreOne’s revenue increased from $755 million in 2018 to $810 million in 2019, with 9 percent growth year-on-year. Therefore, Pfizer CentreOne is a strong commercial entity poised to show solid financial results in 2020 as well. In the fourth quarter of 2019, Pfizer CentreOne reported global revenues of $245 million, which was 20% higher than the activity recorded in Q4, 2018. Pfizer thus attributed Pfizer CentreOne as a key driver towards the 8% increase in the hospital unit observed overall. Pfizer CentreOne includes revenues from Pfizer’s contract manufacturing and active pharmaceutical ingredient sales operation, including sterile injectables contract manufacturing, and revenues related to its manufacturing and supply agreements, including those with Zoetis Inc. Furthermore, in the fourth quarter of 2017, Pfizer sold its equity share in Hisun Pfizer. As a result, effective in the first quarter of 2018, Hisun Pfizer-related revenues, previously reported in emerging markets within legacy All Other LEP and legacy All Other SIP, are now reported in emerging markets within Pfizer CentreOne.

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