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    • Small logo of Teva Pharmaceutical Industries

      Teva Pharmaceutical Industries

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IsraelIsrael

      Sites

      Flag of IndiaIndia
      Flag of SpainSpain
      Flag of NetherlandsNetherlands
      Flag of PolandPoland
      Flag of Czech RepublicCzech Republic
      Flag of IsraelIsrael
      Flag of HungaryHungary
      Flag of ItalyItaly
      Flag of CroatiaCroatia
      Flag of MaltaMalta
      Flag of People's Republic of ChinaPeople's Republic of China
      Flag of Puerto RicoPuerto Rico
      Flag of MexicoMexico
      Flag of United States of AmericaUnited States of America
      Flag of GermanyGermany
      Flag of LithuaniaLithuania
      Flag of United KingdomUnited Kingdom
      Flag of IrelandIreland
      Flag of CanadaCanada

      Regulatory compliance

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

      Audit standards

      GMP (Finished Dosage)
      Sterile FDF
      GMP (APIs)

      Company description

      TAPI stands as the primary global provider of active pharmaceutical ingredients (APIs). With the most extensive range of over 370 high-caliber API products in the industry, we cater to almost 1,000 clients across more than 100 nations. Operating as an independent division under Teva Pharmaceutical Industries, our legacy in the generic API sector spans over 80 years. Situated in close proximity to Tel Aviv, Israel, TAPI boasts a workforce of over 5,000 professionals spread across 19 facilities worldwide. Our cutting-edge manufacturing plants are situated in Italy, Hungary, the Czech Republic, Croatia, Israel, India, China, Mexico, and several other locations.

    • Small logo of Synthon Pharmaceuticals

      Synthon Pharmaceuticals

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of NetherlandsNetherlands

      Sites

      Flag of ArgentinaArgentina
      Flag of ChileChile
      Flag of NetherlandsNetherlands
      Flag of SpainSpain
      Flag of Czech RepublicCzech Republic
      Flag of United States of AmericaUnited States of America

      Regulatory compliance

      KDMF
      JDMF
      FDA
      GDUFA
      CEP COS
      USDMF

      Audit standards

      GMP (Finished Dosage)

      Company description

      Synthon is a leading pharmaceutical company specialized in the development, manufacturing and commercialization of complex generic pharmaceuticals globally.

    • Small logo of Zhejiang Hisun Pharmaceutical Co., Ltd

      Zhejiang Hisun Pharmaceutical Co., Ltd

      Manufacturer
      Audited
      Audit report available
      Non-Compliance Report

      Headquarters

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

      Sites

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

      Regulatory compliance

      EDQM
      GDUFA
      CE
      KDMF
      FDA
      JDMF
      CEP COS
      NDC API
      USDMF

      Audit standards

      GMP (APIs)

      Company description

      Founded in 1956, Zhejiang Hisun Pharmaceutical Co., Ltd. is a comprehensive pharmaceutical enterprise featuring whole chain, multi-regional integration of research, production and marketing as well as development of drug substances and preparations. In 2000, an A-share was issued in order to enter the stock market as a state-owned listed company. As of 2021, Hisun Pharmaceutical is now one of the largest producers of antibiotics and anti-tumor drugs in China and has been listed in the Top 500 Chinese manufacturing enterprises and the Top 100 Chinese pharmaceutical enterprises multiple times. In 2020 Hisun Pharmaceuticals received special recognition from the Joint Prevention and Control Team from the State Council of the People’s Republic of China for their extraordinary efforts in the fight against the epidemic, and Hisun Pharmaceutical was awarded with the “Anti COVID-19 Advanced Collective in Ministry of Industry and Information Technology".

    • Small logo of Qilu Pharmaceutical

      Qilu 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
      KDMF
      JDMF
      FDA
      GDUFA
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (APIs)

      Company description

      Established in 1958, Qilu Pharmaceutical is now one of the leading vertically integrated pharmaceutical companies in China that develops, manufactures and distributes both Finished Dosage Forms (FDFs) and Active Pharmaceutical Ingredients (APIs). Qilu currently has 12 subsidiaries, 11 domestic manufacturing sites and over 3,9000 employees worldwide. Qilu ranks among Top 5 in Chinese pharmaceutical industry in 2022. Dedicated to offering high-quality & trustworthy medicines to the world and improving people‘s well-being, Qilu is vigorously exporting its products to over 100 countries and regions around the world.

    • Small logo of Fresenius Kabi

      Fresenius Kabi

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of GermanyGermany

      Sites

      Flag of United States of AmericaUnited States of America
      Flag of AustriaAustria
      Flag of ItalyItaly
      Flag of IndiaIndia
      Flag of GermanyGermany
      Flag of SwedenSweden
      Flag of People's Republic of ChinaPeople's Republic of China
      Flag of NorwayNorway
      Flag of South AfricaSouth Africa

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      Fresenius Kabi operates as an international healthcare organization specializing in essential medications and advanced technologies for intravenous therapy, blood transfusion, and medical nourishment. The company's portfolio is instrumental in supporting the needs of severely and persistently unwell individuals. Additionally, it provides a variety of active pharmaceutical ingredients (APIs) and finalized goods fabricated within its own establishments

    • Small logo of MSN Life Sciences Pvt. Ltd.

      MSN Life Sciences Pvt. Ltd.

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)
      GMP (Finished Dosage)

      Company description

      MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible.

    • Small logo of Reyoung Pharmaceutical

      Reyoung 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

      KDMF
      USDMF

      Audit standards

      GMP (APIs)

      Company description

      Reyoung Pharmaceutical Co., Ltd., established in 1966, is a modern comprehensive pharmaceutical company. Reyoung is given the title of National Trustworthy Company for Contract and Credit, Grade AAA Credit Company and Credit Company of Shandong Medical Industry. In the past 50 years, Reyoung inherits the mission “Reyoung Pharma., Benefit the public”, insists the business concept “Innovation is the basis, Product quality is first”. Never stop exploration and innovation, forging ahead with determination, and realizing the sustainable healthy development.

    • Small logo of Shilpa Medicare

      Shilpa Medicare

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of PolandPoland

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      We specialize in premium Active Pharmaceutical Ingredients (APIs), Formulations, Innovative Drug Delivery Systems, and Specialty Chemicals using advanced technology with precision to adhere to global standards/specifications. Presently, we are recognized as one of the foremost global providers of Oncology/non-Oncology APIs, intermediates, and Formulations. Shilpa Medicare’s establishments have garnered significant regulatory endorsements from USFDA, EUGMP, TGA, PMDA, Cofepris, Anvisa, and KFDA, encompassing diverse regulatory approved manufacturing standards.

    • Small logo of Hubei Honch Pharmaceutical

      Hubei Honch 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

      NDC API
      CEP COS
      USDMF

      Audit standards

      GMP (APIs)
    • Small logo of Natco Pharma

      Natco Pharma

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of ThailandThailand

      Regulatory compliance

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

      Audit standards

      GMP (APIs)
      GMP (Finished Dosage)

      Company description

      Natco Pharma Limited was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 employees, Natco today has eight manufacturing facilities spread across India with dedicated modern research laboratories, capabilities in New Drug Development, etc. Natco family currently consists of around 4500 employees, we are consistently ranked among fastest growing pharmaceutical companies in India. Natco is well recognized for its innovation in Pharmaceutical R&D.

    • Small logo of Sun Pharmaceutical Industries

      Sun Pharmaceutical Industries

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of AustraliaAustralia
      Flag of NetherlandsNetherlands
      Flag of United States of AmericaUnited States of America
      Flag of United KingdomUnited Kingdom
      Flag of HungaryHungary
      Flag of IsraelIsrael
      Flag of IrelandIreland
      Flag of CanadaCanada

      Regulatory compliance

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

      Audit standards

      GMP (APIs)
      GMP (Finished Dosage)

      Company description

      Sun Pharma is a global, comprehensive, specialized pharmaceutical company with production facilities for API and FDF in India, the United States, Latin America, and Europe. It produces and sells a wide range of pharmaceutical formulations as branded generics and generic drugs in India, the US, and various other global markets. It is supported by 2 advanced R&D Centers with a team of over 600 scientists for projects in Chemical Synthesis, Clinical Research, and formulation development. Sun is a frontrunner in specific therapy areas and possesses robust expertise in product development, process chemistry, and manufacturing.

    • Small logo of Viatris

      Viatris

      Manufacturer

      Headquarters

      Flag of United States of AmericaUnited States of America

      Sites

      Flag of United States of AmericaUnited States of America
      Flag of CanadaCanada
      Flag of IrelandIreland
      Flag of IndiaIndia
      Flag of PolandPoland
      Flag of Puerto RicoPuerto Rico
      Flag of AustraliaAustralia

      Regulatory compliance

      WHO GMP
      FDA
      GDUFA
      EDQM
      GDP

      Company description

      VIATRIS™ represents a fresh approach to healthcare, dedicated to ensuring medicine accessibility, promoting sustainable practices, pioneering creative remedies, and enhancing patient results. Founded in 2020 through the merger of Mylan and Upjohn, Viatris unites top-notch scientific, production and distribution skills with established regulatory, medical and commercial proficiencies.

    • Small logo of Dr. Reddy's Laboratories

      Dr. Reddy's Laboratories

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of MexicoMexico
      Flag of United KingdomUnited Kingdom
      Flag of United States of AmericaUnited States of America
      Flag of RomaniaRomania

      Regulatory compliance

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

      Audit standards

      GMP (Finished Dosage)
      GMP (APIs)
      GMP (Excipients)

      Company description

      Dr. Reddy’s Laboratories Ltd. functions as an integrated pharmaceutical firm, dedicated to supplying cost-effective and innovative medications to promote healthier lifestyles. With a focus on Pharmaceutical Services & Active Ingredients, Global Generics, and Proprietary Products, Dr. Reddy’s delivers a range of products and services such as APIs, customized pharmaceutical services, generics, biosimilars, and distinct formulations. The primary therapeutic areas of concentration encompass gastro-intestinal, cardiovascular, diabetology, oncology, pain management, and dermatology. Dr. Reddy’s has a presence in various global markets, with significant engagements in the USA, Europe, India, Russia, and other CIS nations.

    • Small logo of Cipla

      Cipla

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of NetherlandsNetherlands
      Flag of United KingdomUnited Kingdom
      Flag of BelgiumBelgium
      Flag of United States of AmericaUnited States of America

      Regulatory compliance

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

      Audit standards

      GMP (Finished Dosage)

      Company description

      Cipla, as an organisation has been built brick-by-brick on the foundation of care. Caring For Life has always been and continues to remain, our guiding purpose. Driven by the same purpose, we have extended our presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. To make healthcare more affordable globally, we are deepening our presence in the key markets of India, South Africa, the U.S. among other economies of the emerging world. For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of Caring for Life and deep-rooted community links wherever it is present, make it a partner of choice for global health bodies and stakeholders.

    • Small logo of Hetero Drugs

      Hetero Drugs

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of MaltaMalta

      Regulatory compliance

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

      Audit standards

      GMP (Finished Dosage)
      GMP (APIs)

      Company description

      We are one of world’s leading producers of key Active Pharmaceutical Ingredients (APIs) and generic formulations with presence in 140+ countries and backed by 30 years of experience in the pharma sector. We endeavour to serve patients by moulding science and technology into therapies to improve health outcomes and people’s lives.

    • Small logo of Fresenius

      Fresenius

      Manufacturer

      Headquarters

      Flag of GermanyGermany

      Sites

      Flag of United States of AmericaUnited States of America
      Flag of AustriaAustria
      Flag of NorwayNorway
      Flag of South AfricaSouth Africa
      Flag of SwedenSweden
      Flag of IndiaIndia
      Flag of GermanyGermany
      Flag of ItalyItaly
      Flag of MexicoMexico

      Regulatory compliance

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

      Company description

      Fresenius is an international healthcare conglomerate offering products and services for kidney dialysis, hospital care, and home medical treatment. The Fresenius Group comprises four distinct business segments - Fresenius Medical Care, Fresenius Kabi, Fresenius Helios, and Fresenius Vamed - each managing its own global operations.

    • Small logo of Laurus Labs

      Laurus Labs

      Manufacturer
      Audited

      Sites

      Flag of IndiaIndia
      Flag of United KingdomUnited Kingdom

      Regulatory compliance

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

      Company description

      In just over a decade, Laurus has positioned itself as one of the largest and most innovative API producers globally. Expanding upon its established expertise in chemistry, Laurus has recently adopted full vertical integration, including a strong finished dosage capacity, dedicated capacity for backward integration, and also Synthesis R&D operations in India and the USA.

    • Small logo of Granules India

      Granules India

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)
      GMP (Finished Dosage)

      Company description

      Granules India Limited is a rapidly expanding pharmaceutical company with top-notch amenities for APIs, PFIs and Finished Dosages, catering to clients in more than 60 nations. We are dedicated to upholding high standards in production, excellence and client relations. Our main office is situated in Hyderabad, and we also have branches in the United States, United Kingdom, Colombia and China, as well as production facilities in India and China.

    • Small logo of Gland Pharma

      Gland Pharma

      Manufacturer
      Audited

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      EDQM
      WHO GMP
      GDUFA
      EU WC
      KDMF
      FDA
      USDMF
      CEP COS

      Company description

      Established in 1978 as a specialized facility for Small Volume Parenterals (SVPs), Gland Pharma has evolved into a forward-thinking and quality-focused organization catering to the pharmaceutical requirements of diverse global markets. The company possesses state-of-the-art facilities for injectables established in partnership with Vetter Group, Germany, providing Gland Pharma a technological advantage in injectables, particularly in Pre Filled Syringes.

    • Acebright Group

      Manufacturer

      Headquarters

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

      Sites

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

      Regulatory compliance

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

      Company description

      Shanghai Acebright Pharmaceuticals Group Co Ltd was established in 1996. Over 12 manufacturing facilities conforming to GMP standards are situated in China and India. The company specializes in a range of Vitamin products, ARV APIs & intermediates, and oncology APIs & finished pharmaceutical products. It serves as an integrated CDMO service partner from R&D to commercial manufacturing.

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