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    Pharmaceutical manufacturers of Progesterone

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    28results for pharmaceutical manufacturers of Progesterone

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    • Productos Químicos Naturales S.A. de C.V.

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of MexicoMexico

      Sites

      Flag of MexicoMexico

      Regulatory compliance

      USDMF
      NDC API
      CEP COS

      Audit standards

      GMP (APIs)

      Company description

      The company was established as a partnership between Syntex (the company co-founded by the American chemist Dr. Russell Marker) and Beneficio Acayucan (a company growing and harvesting wild yam). The first name of the company was Productos Químicos Naturales Syntex S.A. de C.V. In 1963 it was acquired by the German pharmaceutical leader in the production of hormonal products for human use, Schering AG, which is now part of Bayer, based in Germany. At the same time, the name was changed to Productos Químicos Naturales S.A. de C.V., or Proquina for short. In January 2007, following the acquisition of Schering AG by the Bayer Group, Proquina became a subsidiary of Bayer. Proquina has over 45 years of experience in the production of active pharmaceutical ingredients and intermediates (mainly steroid hormones) and uses a modern production infrastructure for its chemical processes. Proquina has customers in Europe, America, and Japan. Proquina has been inspected since 1990 12 times by COFEPRIS(México), 9 times by FDA(USA), 2 times by EDQM (Europe), 2 times by TGA (Australia), and 2 times by PMDA(Japan), with approval inspection in all of them. Around ten to fifteen global customer audits per year were received from 1990 to date. Additionally, 4 corporative audits were conducted since 1990.

    • Small logo of Catalent

      Catalent

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of United States of AmericaUnited States of America

      Sites

      Flag of ItalyItaly
      Flag of JapanJapan
      Flag of BelgiumBelgium
      Flag of FranceFrance
      Flag of United KingdomUnited Kingdom
      Flag of United States of AmericaUnited States of America
      Flag of ArgentinaArgentina
      Flag of GermanyGermany
      Flag of CanadaCanada
      Flag of AustraliaAustralia
      Flag of Puerto RicoPuerto Rico

      Regulatory compliance

      EDQM
      GDUFA
      JDMF
      FDA
      NDC API
      USDMF

      Audit standards

      GMP (Finished Dosage)

      Company description

      Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad, deep-scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred Contract Development and Manufacturing Organization (CDMO) partner for personalized medicines, blockbuster drugs and consumer health brand extensions. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 80 billion doses of nearly 8,000 products annually. Its rapidly growing expert workforce exceeds 18,000, including more than 3,000 scientists and technicians. Headquartered in Somerset, New Jersey, Catalent, Inc. (NYSE:CTLT), is in S&P 500® company, and generated nearly $5 billion in revenue in its 2022 fiscal year.

    • Small logo of Pfizer

      Pfizer

      Manufacturer
      Audited
      Warning letter

      Headquarters

      Flag of United States of AmericaUnited States of America

      Sites

      Flag of IndiaIndia
      Flag of United States of AmericaUnited States of America
      Flag of IrelandIreland
      Flag of SingaporeSingapore
      Flag of BelgiumBelgium
      Flag of ItalyItaly
      Flag of Puerto RicoPuerto Rico
      Flag of People's Republic of ChinaPeople's Republic of China
      Flag of CanadaCanada
      Flag of GermanyGermany

      Regulatory compliance

      EDQM
      WHO GMP
      FDA
      JDMF
      KDMF
      GDUFA
      EU WC
      GDP
      USDMF
      CEP COS
      NDC API

      Company description

      Pfizer CentreOne® is a completely distinct global contract development and manufacturing organization (CDMO), as well as a prominent provider of specialty APIs and intermediates. Supported by resources from Pfizer, we have provided technical knowledge, regulatory assistance, and long-term supply for more than 40 years. With a network of over 35 sites spanning six continents, we are capable of securely and effectively guiding complex compounds from development to commercial manufacture. For more details, please visit http://www.pfizercentreone.com

    • Small logo of Hubei Gedian Humanwell Pharmaceutical

      Hubei Gedian Humanwell Pharmaceutical

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of People's Republic of ChinaPeople's Republic of China

      Sites

      Flag of People's Republic of ChinaPeople's Republic of China

      Regulatory compliance

      EDQM
      FDA
      KDMF
      GDUFA
      EU WC
      JDMF
      USDMF
      NDC API
      CEP COS

      Audit standards

      GMP (APIs)
    • Lab Service

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of FranceFrance

      Sites

      Flag of FranceFrance

      Regulatory compliance

      FDA
      GDUFA

      Audit standards

      GMP (APIs)
    • Actavis

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of IrelandIreland

      Sites

      Flag of United States of AmericaUnited States of America
      Flag of ItalyItaly
      Flag of IndiaIndia
      Flag of MaltaMalta
      Flag of United KingdomUnited Kingdom
      Flag of ArgentinaArgentina
      Flag of TürkiyeTürkiye
      Flag of BrazilBrazil
      Flag of MexicoMexico
      Flag of TaiwanTaiwan
      Flag of UruguayUruguay
      Flag of IrelandIreland
      Flag of BulgariaBulgaria
      Flag of RomaniaRomania
      Flag of Puerto RicoPuerto Rico

      Regulatory compliance

      EDQM
      JDMF
      FDA
      GDUFA
      GDP
      EU WC
      NDC API
      USDMF
      CEP COS

      Audit standards

      GMP (Finished Dosage)
    • Small logo of Aspen Pharmacare Holdings

      Aspen Pharmacare Holdings

      Manufacturer
      Audited

      Headquarters

      Flag of South AfricaSouth Africa

      Sites

      Flag of NetherlandsNetherlands
      Flag of GermanyGermany
      Flag of South AfricaSouth Africa
      Flag of AustraliaAustralia
      Flag of BelgiumBelgium
      Flag of SwedenSweden
      Flag of United States of AmericaUnited States of America
      Flag of FranceFrance
      Flag of IrelandIreland

      Regulatory compliance

      FDA
      GMP
      ISO
      EDQM
      GDUFA
      KDMF
      JDMF
      GDP
      USDMF
      NDC API
      CEP COS

      Audit standards

      GMP (APIs)

      Company description

      Aspen CDMO offers customized manufacturing services for Finished Dosage Forms across two continents: Europe and Africa. The primary dosage forms include injectables such as pre-filled syringes, liquid and lyophilized vials, BFS ampoules, and infusion bags, as well as tablets, creams, ointments, sprays, and BFS ampoules for nebulizers. It operates three advanced facilities in France.

    • Small logo of Symbiotec Pharmalab

      Symbiotec Pharmalab

      Manufacturer

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      EDQM
      WHO GMP
      GDUFA
      EU WC
      KDMF
      FDA
      JDMF
      USDMF
      NDC API
      CEP COS

      Company description

      Symbiotec Pharmalab Pvt. Ltd is a prominent manufacturer of Active Pharmaceutical Ingredients (APIs) for Cortico Steroids and Sex Hormones, serving over 35 markets, including North America, Europe, Israel, and Japan. Established in 1995 in Central India, the company holds accreditations from US-FDA, EU-GMP, and WHO-GMP. It has received eighteen (18) Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) from the European Directorate for the Quality of Medicines (EDQM) and has filed several Drug Master Files (DMFs) with EDQM and FDA. Symbiotec is dedicated to providing cGMP compliant material with comprehensive regulatory support, coupled with the advantage of lower production costs in Asia. The company offers Lyophilized Sterile and Micronized Steroids and Hormones with a particle size of up to 5 microns. For a complete range of products and further details, please visit their website.

    • Small logo of F.I.S. Fabbrica Italiana Sintetici

      F.I.S. Fabbrica Italiana Sintetici

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of ItalyItaly

      Sites

      Flag of ItalyItaly
      Flag of SwitzerlandSwitzerland

      Regulatory compliance

      EDQM
      KDMF
      GDUFA
      JDMF
      FDA
      CEP COS
      NDC API
      USDMF

      Audit standards

      GMP (APIs)

      Company description

      Fisvi is a distinguished Italian company with a proud heritage in the manufacturing and innovation sectors. Specializing in advanced materials and cutting-edge solutions, Fisvi offers a wide range of products tailored to meet the demands of various industries, including construction, automotive, and industrial applications. Their product lineup includes high-quality insulation materials, adhesives, sealants, and other specialized components designed to enhance performance and durability.

    • Zhejiang Xianju Pharmaceutical Co., Ltd

      Manufacturer

      Headquarters

      Flag of People's Republic of ChinaPeople's Republic of China

      Sites

      Flag of People's Republic of ChinaPeople's Republic of China

      Regulatory compliance

      EDQM
      CEP COS
      USDMF
      JDMF
      KDMF
      GDUFA
      FDA
      NDC API

      Company description

      Founded as Xianju Pharmacy Plant in 1972, Xianju Pharmaceutical Co., Ltd. (stock code: 002332) practices the corporate philosophy of “ your health and happiness, my sincerity and service” and focuses on steroid hormones with the vision of “ Becoming the one of the Top 10 steroid hormone suppliers in the world and a business well-received among customers and employees.” It has a total capital stock of 989.204866 million yuan and more than 3600 employees. As a key high-tech enterprise of the National Torch Plan, the company ranked 67th among the top 100 in the Chinese pharmaceutical industry in 2020 with a provincial steroid medicine engineering technology research center in Zhejiang Province and a national post-doctoral center. As the only company holding fast to the business pattern integrating bulk pharmaceutical chemicals and preparations, the company specializes in the research, production and sale of bulk pharmaceutical chemicals and steroid preparations. In its product development, the company sticks to the four major fields of health care (gynecology, anesthesiology, respiratory medicine, and dermatology) to build mixes of products and services. The company has established long-term partnership with more than 20 domestic prestigious research institutes and universities including the Shanghai institute of Organic Chemistry, Chinese Academy of Sciences, Zhejiang University and China Pharmaceutical University to bring in senior researchers and gradually align with the new drug development in the world. The company has formed a technical framework that originates from overseas high-end research institutions, assimilates through the research institutions in Hangzhou and Xianju and Implements them with the base in Xianju. Under the company, there are 20 wholly-owned and holding subsidiaries such as time Xianju Pharmaceutical Co., Ltd. The company has three core manufacturing platforms, which are Xianju Yangfu bulk pharmaceutical chemicals production zone, Xianju Yangfu preparation production zone and Linhai Yangfu productions zone at home and two standard bulk pharmaceutical chemicals plants under the name of NewChem, its subsidiary in Italy. Xianju Pharma advocates the culture celebrating authenticity, win-win results and innovation and core values of honesty, hard work, openness, studiousness, responsibility and mutual benefit. Upholding the strategic objective of achieving win-win results with customers, enterprises, employees and communities, the company promotes the values that individuals’ value is reflected when they benefit their communities and companies. In its future development, the company will continue optimizing its business management, developing high-tech products and leverage on its large business size to achieve high-quality development and make contributions to the health care of mankind.

    • Small logo of Shree Venkatesh International

      Shree Venkatesh International

      Manufacturer

      Headquarters

      Flag of IndiaIndia

      Regulatory compliance

      GMP

      Company description

      Shree Venkatesh International Limited has established itself as a rapidly growing and distinguished Indian company dedicated to the production, promotion, and export of Hormonal products. Our state-of-the-art facility is equipped with advanced technologies specifically designed for a wide range of Gynecological, IVFs, and Contraceptives Hormonal products. At Shree Venkatesh International Limited, we tirelessly strive to develop highly efficient and safe hormonal products and make them accessible at the most competitive prices globally. Our portfolio includes Injectables, lyophilized powder, and hormonal Oral tablets, contributing to the enhancement of reproductive health on a global scale. Our WHO-GMP (India) plant has been inspected and approved by regulatory bodies in Yemen (SBDMA), Kenya (PPB), Nigeria (NAFDAC), Cambodia, and the Philippines. We have plans to extend our product reach to countries in the CIS, African, Southern Asian, Southern American, PIC/s, and MENA regions. For further information, please visit www.shreevenkatesh.com. Shree Venkatesh International Limited is an ISO9001:2008 Certified company registered under the Registrar of Companies Act, specializing in the export of Generic Medicines, Pharmaceutical formulations, and Bulk drugs from India. The company is based in Gujarat, which is renowned as the Manufacturing Hub for Pharmaceutical formulations in India.

    • Sigma Tau

      Manufacturer

      Headquarters

      Flag of United States of AmericaUnited States of America

      Sites

      Flag of ItalyItaly
      Flag of United States of AmericaUnited States of America
      Flag of SpainSpain

      Regulatory compliance

      FDA
      EDQM
      USDMF
    • Signa

      Manufacturer

      Headquarters

      Flag of MexicoMexico

      Sites

      Flag of MexicoMexico

      Regulatory compliance

      FDA
      GDUFA
      USDMF
      CEP COS
      KDMF
      JDMF
    • Industriale Chimica

      Manufacturer
      Audited

      Headquarters

      Flag of ItalyItaly

      Sites

      Flag of ItalyItaly
      Flag of FranceFrance

      Regulatory compliance

      EDQM
      JDMF
      KDMF
      FDA
      GDUFA
      USDMF
      NDC API
      CEP COS
    • Chongqing Huapont Pharmaceutical

      Manufacturer

      Headquarters

      Flag of People's Republic of ChinaPeople's Republic of China

      Sites

      Flag of People's Republic of ChinaPeople's Republic of China

      Regulatory compliance

      EDQM
      FDA
      JDMF
      KDMF
      GDUFA
      CEP COS
      NDC API
      USDMF
    • Small logo of Naari

      Naari

      Manufacturer

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      EU WC
      WHO GMP
      USDMF

      Company description

      Indo Phyto Chemicals, IPC, operates as a fully integrated manufacturer of steroids and hormones, specializing in potent compounds and intricate chemical processes. The company's production capabilities encompass the fermentation of phytosterols for the synthesis of steroid building blocks, as well as the production of intermediates and APIs through synthesis. Additionally, IPC has internal micronization facilities for APIs to ensure the delivery of top-quality products.

    • Chemo Biosynthesis

      Manufacturer
      Audited

      Headquarters

      Flag of ItalyItaly

      Sites

      Flag of MexicoMexico
      Flag of ItalyItaly
      Flag of SpainSpain
      Flag of ArgentinaArgentina

      Regulatory compliance

      FDA
      KDMF
      EDQM
      GDUFA
      CEP COS

      Company description

      Chemo Biosynthesis operates as a division of the Insud Pharma group and specializes in the production of microbial fermentation and chemical API’s. The company provides tailored solutions in pharmaceuticals (for both human and veterinary use) and food additives, catering to clients from across the globe. It is among the leading microbial contract manufacturing facilities in Europe, with a substantial fermentation capacity of around 800 m3, and is free from beta-lactam.

    • Laboratorio Syntex

      Manufacturer

      Headquarters

      Flag of ArgentinaArgentina

      Sites

      Flag of ArgentinaArgentina

      Regulatory compliance

      JDMF
      KDMF
      USDMF
      CEP COS
    • Small logo of Corona Remedies

      Corona Remedies

      Manufacturer

      Headquarters

      Flag of IndiaIndia

      Regulatory compliance

      GMP

      Company description

      We are CORONA Remedies Pvt. Ltd. Our inception dates back to 2004, with a dedication to enhancing the quality of healthcare for all by leading in the exploration, production, and promotion of premium products. Our presence spans across India, with rapid recognition among the medical community, and our pioneering initiatives have proudly established us as one of India’s newest companies to rank among the top 35 pharmaceutical firms

    • Small logo of Organon

      Organon

      Manufacturer

      Headquarters

      Flag of United States of AmericaUnited States of America

      Regulatory compliance

      GDP
      USDMF

      Company description

      Organon, a worldwide healthcare corporation established following a separation from Merck (known as MSD beyond the boundaries of the U.S. and Canada), is dedicated to providing impactful medications and remedies for a healthier daily life. With a portfolio encompassing over 60 medications and various products focusing on areas such as reproductive health, heart disease, dermatology, allergies, and asthma, we strive to make these vital treatments accessible globally. Our international presence spans across more than 140 markets, and we believe that the variety in our operations lays the groundwork for sustainable growth, enabling continuous investment and progress.

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