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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 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 LEK Pharmaceuticals

      LEK Pharmaceuticals

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of SloveniaSlovenia

      Sites

      Flag of SloveniaSlovenia
      Flag of United States of AmericaUnited States of America
      Flag of SpainSpain
      Flag of CanadaCanada
      Flag of AustriaAustria
      Flag of GermanyGermany
      Flag of FranceFrance
      Flag of NetherlandsNetherlands
      Flag of BelgiumBelgium
      Flag of DenmarkDenmark
      Flag of RomaniaRomania
      Flag of ItalyItaly

      Regulatory compliance

      EDQM
      KDMF
      GDUFA
      FDA
      JDMF
      CEP COS
      USDMF
      NDC API

      Audit standards

      GMP (APIs)
      GMP (Finished Dosage)
    • Small logo of Jiangsu Nhwa Pharmaceutical

      Jiangsu Nhwa Pharmaceutical

      Manufacturer
      Audited
      Audit report available
      Warning letter

      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

      JDMF
      USDMF
      CEP COS

      Audit standards

      GMP (APIs)

      Company description

      Jiangsu Nhwa Pharmaceutical Co., Ltd. was initially founded in 1978. In year 2008, Nhwa listed on the Shenzhen stock exchange with the stock code 002262. NHWA Pharma integrates R&D, production and sales together, as national psychiatric drugs designated unit, national high-tech enterprise, China’s top 100 pharmaceutical enterprises, national intellectual property rights demonstration unit, national "20 years 20 star" medical quality management enterprise star unit, international environmental certification (ISO14000) confirmed enterprise, the first batch of innovative enterprises in Jiangsu province, and vice President unit of China narcotic drug association.

    • Small logo of Aurobindo Pharma

      Aurobindo Pharma

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of United States of AmericaUnited States of America
      Flag of NetherlandsNetherlands

      Regulatory compliance

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

      Audit standards

      GMP (APIs)
      GMP (Finished Dosage)

      Company description

      Founded in 1986 by Mr. P. V. Ramprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born of a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry. Aurobindo Pharma became a public company in 1992 and listed its shares on the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillins, it has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and anti-biotics, among others.

    • 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 Apotex

      Apotex

      Manufacturer

      Headquarters

      Flag of CanadaCanada

      Sites

      Flag of CanadaCanada
      Flag of NetherlandsNetherlands
      Flag of BahamasBahamas
      Flag of IndiaIndia
      Flag of SwitzerlandSwitzerland
      Flag of MexicoMexico
      Flag of BelgiumBelgium

      Regulatory compliance

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

      Company description

      For more than 40 years, Apotex has been a reputable name in the Canadian pharmaceutical industry, offering patients increased availability to high-quality, cost-effective medications

    • Small logo of Chromo Laboratories

      Chromo Laboratories

      Manufacturer
      Audited
      Audit report available

      Sites

      Flag of IndiaIndia
      Flag of PolandPoland

      Regulatory compliance

      FDA
      GDUFA
      EU WC
      CEP COS
      NDC API
      USDMF

      Audit standards

      GMP (APIs)

      Company description

      Chromo Labs operates as a fully integrated pharmaceutical company, engaging in international, active pharmaceutical ingredient (API), and oral solid dosage (OSD) manufacturing. With approvals from USFDA, EDQM, WHO GENEVA, COFEPRIS, ANVISA, and EUWC, Chromo API holds 19 CEP approvals and has 7 CEPs under review. Additionally, Chromo API has filed 35 USDMFs, 6 of which are currently commercialized. The company possesses a comprehensive backup API portfolio, supported by Chromo Medcare and Gensynth Pharmachem.

    • HEC Pharm

      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
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (APIs)

      Company description

      HEC Pharm Co has obtained approval from the FDA and EDQM as a pharmaceutical manufacturer of both active pharmaceutical ingredients (API) and dosage forms. Presently, HEC is the largest global producer of Macrolides API, including Erythromycin and its derivatives. Sunshine Lake Pharma Co, a subsidiary of HEC Pharm, was established to supply finished pharmaceuticals (dosage forms) to the markets of the United States and European Union (EU).

    • Small logo of Cadila Pharmaceuticals

      Cadila Pharmaceuticals

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      Cadila Pharmaceuticals Ltd. is one of the largest privately-held pharmaceutical companies in India. Over the past seven decades, we have been developing and manufacturing affordable medicines for patients around the world. Our innovation-led drug discovery processes ensure the health and well-being of people around the world. Our enhanced investment in innovation and a strong track record in research and development have produced medical miracles that have changed lives and made a profound impact on real life.

    • Small logo of Macleods Pharmaceuticals

      Macleods Pharmaceuticals

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (Finished Dosage)
      GMP (APIs)
    • Small logo of Moehs Iberica

      Moehs Iberica

      Manufacturer
      Audited

      Headquarters

      Flag of SpainSpain

      Sites

      Flag of SpainSpain

      Regulatory compliance

      EDQM
      KDMF
      JDMF
      USDMF
      CEP COS
      NDC API

      Company description

      Moehs Ibérica is the headquarters of the MOEHS Group. Moehs Ibérica currently has 138 employees in the following departments: Accounting/Treasury, Purchasing/Logistics, Sales/Marketing, Human Resources, IT, Quality Assurance/Regulatory Affairs, Research and Intellectual Property. It provides services to the entire group and each of its subsidiaries. In addition, it has its own R&D building with all its services and a plant dedicated to the production of small quantities of ingredients for the pharmaceutical industry, as well as a plant for the manufacture of High Potency Active Ingredients.

    • Small logo of Lee Pharma

      Lee Pharma

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      Lee Pharma Limited was established in 1997 in India it is a research-driven company with a critical focus on the development, synthesis, and commercialization of new products and cost-effective processes. ​ We manufacture several intermediate chemicals, Active Pharmaceutical Ingredients & Semi-finished Dosage Forms (Pellets & Granules), and Finished Formulations. Our expertise in the field won us, numerous clients, in India as well as across the globe. Lee Pharma Manufacturing facilities are approved by several international regulatory bodies such as USFDA, EUGMP, WHO GMP etc.

    • 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 Sun Pharmaceutical Industries

      Sun Pharmaceutical Industries

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of AustraliaAustralia
      Flag of IndiaIndia
      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 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.

    • Nosch Labs

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      EDQM
      EU WC
      KDMF
      JDMF
      CEP COS
      USDMF

      Audit standards

      GMP (APIs)
      GMP (Finished Dosage)

      Company description

      Dream that drives us at Nosch. The laudable goal that we aim for. The vision that suffuses us with the passion to innovate and excel. Over the past twenty one years, we have been ceaselessly engaged in a quest to sustain and improve the quality of life through creating safe pharmaceutical solutions. Our competencies have grown to embrace the entire pharmaceutical value chain-APIs and semi-finished Formulations. Today, with an impeccable reputation for uncompromising quality and timely delivery, Nosch has emerged as the partner of choice across the world.

    • Small logo of Solara Active Pharma Sciences

      Solara Active Pharma Sciences

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      Solara is an API manufacturer focused on research and customer satisfaction, operating in over 75 countries. They specialize in producing APIs for niche therapeutic categories, including complex products like polymer-based APIs and injectable APIs. The company has a team of experienced scientists supported by 6 manufacturing facilities and 2 R&D centers. Additionally, Solara offers Contract Research and Manufacturing Services (CRAMS) from discovery to late phase commercial manufacturing. Solara Active Pharma Sciences, with roots in Strides Shasun Ltd. and Sequent Scientific Ltd., is committed to providing value-based products while prioritizing customer needs. The company has 140+ scientists working at 2 R&D centers and 4 API manufacturing facilities, all with global approvals and 2 dedicated R&D facilities.

    • Small logo of Neuland Laboratories

      Neuland Laboratories

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      Established in 1984, Neuland Laboratories Limited is a publicly traded company based in Hyderabad, India. The organization offers solutions throughout the entire range of the pharmaceutical industry's chemical needs, from synthesizing library compounds to providing NCEs and advanced intermediates at different stages in the clinical life cycle, as well as for commercial launch. Neuland's specialty lies in the production of APIs and advanced intermediates from its facilities approved by the USFDA. Its primary expertise is the application of effective process chemistry to manufacturing in a compliant regulatory setting.

    • Small logo of Jubilant Ingrevia

      Jubilant Ingrevia

      Manufacturer

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of United States of AmericaUnited States of America
      Flag of CanadaCanada

      Regulatory compliance

      GDUFA
      EU WC
      WHO GMP
      FDA
      EDQM
      USDMF
      NDC API

      Company description

      Jubilant Ingrevia Limited is an internationally integrated provider of Life Science products and Innovative Solutions, catering to Pharmaceutical, Nutrition, Agrochemical, Consumer, and Industrial clients with tailored products and solutions that are pioneering, cost-efficient, and adhere to outstanding quality standards. Its range also encompasses personalized research and production for pharmaceutical and agrochemical customers on an exclusive basis. The organization provides a selection of over 125 products & pioneering solutions utilizing more than 35 essential chemistry and technology platforms across its three business segments of Speciality Chemicals, Nutrition & Health Solutions, and Chemical Intermediates. With a team of over 2,100 employees serving more than 1,500 customers in over 50 countries worldwide, the company is motivated to bring value to millions of lives through innovations and state-of-the-art technology. For more information, please visit www.jubilantingrevia.com. Business Segments: Speciality Chemicals consists of distinct building blocks such as Pyridine and Picolines, Cyanopyridines, Piperidine, and their value-added derivatives. The company has recently ventured into Diketene Chemistry, currently producing Diketene esters & amide with several other Diketene derivatives in the pipeline. The Speciality Chemicals products are utilized in the production of a variety of Agrochemicals, Pharmaceuticals, Nutrition, Fine chemicals, Oilfield chemicals, Electronics, and Solvents. Nutrition & Health Solutions caters to Human & Animal Nutrition, Pharmaceutical & Personal Care segment/applications and comprises three businesses - Nutrition & Health Ingredients, Animal Nutrition & Health Solutions, and Human Nutrition & Health Solutions. Chemical Intermediates manufactures a range of Chemical Intermediates including Acetyl Products and Speciality Ethanol.

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