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    • Small logo of Esteve Quimica

      Esteve Quimica

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of SpainSpain

      Sites

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

      Regulatory compliance

      GMP
      EDQM
      KDMF
      JDMF
      FDA
      GDUFA
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (APIs)

      Company description

      At Esteve Quimica, we are dedicated to the healthcare sector by providing support for the advancement and commercialization of products that enhance the health of patients. Established in 1966, our company remains privately owned despite being a part of ESTEVE, one of the largest pharmaceutical groups in Spain. Our current focus is on the development and production of small molecule intermediates and active ingredients for innovator companies, operating as a dedicated third-party contract business.

    • Small logo of Unichem Laboratories

      Unichem Laboratories

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of SpainSpain

      Regulatory compliance

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

      Audit standards

      GMP (APIs)
      GMP (Finished Dosage)

      Company description

      Unichem Laboratories was founded in 1944 by Late Mr. Amrut Mody, a pioneer in the Indian pharmaceuticals business. With a rich tradition of unwavering quality and reliability, Unichem brings together a unique blend of modern, value-added research and deep knowledge of the Indian pharmaceuticals industry.ç

    • 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 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 Helm

      Helm

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of GermanyGermany

      Sites

      Flag of GermanyGermany
      Flag of MexicoMexico
      Flag of PortugalPortugal

      Regulatory compliance

      GDP
      CEP COS

      Audit standards

      GDP (Distribution)

      Company description

      HELM AG, a company based in Hamburg and owned by a family, has a 120-year history in 4 diverse sectors: Pharmaceuticals, Chemicals, Crop Protection, and Crop Nutrition. With a global presence through subsidiaries, sales offices, and partnerships, HELM is recognized as one of the world's leading independent marketing firms for chemicals. At HELM Pharma, our goal is to establish ourselves as the top B2B project and marketing platform, offering a distinctive partnership experience. In the marketing of our products, we deliver a comprehensive range of services for our business associates.

    • Small logo of Zydus Lifesciences

      Zydus Lifesciences

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of FranceFrance
      Flag of United States of AmericaUnited States of America

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      The Zydus group is based in Ahmedabad, India, and is placed 4th in the Indian pharmaceutical sector. Zydus' global operations have a substantial presence in the regulated markets of the US, Europe (specifically France and Spain), and in the prominent markets of Latin America and South Africa. It also has a significant presence in 25 other developing markets around the world.

    • Small logo of Uquifa

      Uquifa

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of SpainSpain

      Sites

      Flag of SpainSpain
      Flag of MexicoMexico

      Regulatory compliance

      EDQM
      JDMF
      KDMF
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (APIs)

      Company description

      Bringing 86 years of expertise, UQUIFA'S operational approach is built on a fusion of a high-quality production platform and a proven history of service and dependability. UQUIFA specializes in the production of Active Pharmaceutical Ingredients (APIs), Intermediates, and RSM's for the pharmaceutical and animal health sectors on a global scale. The organization runs 2 production facilities (located in Spain and Mexico) with stringent compliance to all regulatory standards. These facilities operate under cGMP conditions and have undergone evaluation and endorsement from prominent global pharmaceutical companies.

    • 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 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 Olon

      Olon

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of ItalyItaly

      Sites

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

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      OLON Group is a prominent worldwide firm specializing in the creation and manufacture of active pharmaceutical ingredients for CDMO and Generics. It serves as a dependable and preferred partner for the pharmaceutical, biotech, and specialty ingredients sectors. With a 2021 turnover of 580 million dollars, OLON provides 300 APIs for the Generic market. The company benefits from a workforce of 2,300 employees, including a highly skilled R&D team of over 300 individuals. This enables OLON to offer comprehensive integrated packages and services to facilitate the full development of APIs, leveraging extensive expertise in both Chemical and Biological processes, all within a full cGMP and regulatory framework. OLON holds approximately 160 active US DMFs and 79 granted CoS. OLON's headquarters is located in Rodano, near Milan, Italy, and it operates 11 manufacturing facilities - 8 in Italy, 1 in Spain, 1 in the USA, and 1 in India. These facilities are designed in accordance with the most stringent international standards. Additionally, OLON has 3 branch offices in Hamburg (Germany), Florham Park, NJ (USA), and Shanghai (China).

    • Small logo of Ipca Laboratories

      Ipca Laboratories

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of PolandPoland

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      For more than 60 years, Ipca has been a crucial healthcare partner in over 120 countries across the 6 continents. We are a fully-integrated pharmaceutical company that manufactures over 350 formulations and 80 APIs for various therapeutic segments. Today, we are one of the world’s largest manufacturers and suppliers of over a dozen APIs. These are produced from scratch at fully-automated manufacturing facilities, approved by the world’s most discerning drug regulatory authorities like UK-MHRA, EDQM-Europe, and WHO-Geneva, among others.

    • Micro Labs

      Manufacturer
      Audited
      Audit report available
      Non-Compliance Report

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      We are a technology-focused, multi-dimensional pharmaceutical company having state-of-the-art manufacturing capabilities in diverse therapeutic areas such as Cardiology, Diabetology, Pain Management, Dermatology, Ophthalmology, Neurology and more. We strive towards unlocking the power of science to provide access to affordable and innovative medicines to improve health outcomes and make a difference in people's lives across the globe. As we continue to champion the cause of Make-in-India through our steady expansion across various Indian states, we create job opportunities and drive social responsibility programs in education, healthcare, rural development and environmental protection to add value to our local communities. Our roadmap is to continue investing in discovering, developing, manufacturing, and commercializing innovative medicines. Meeting the growth and profitability goals through successful innovation in digital healthcare trends and commercial excellence will continue to be the driving factors over the next decade.

    • Small logo of Arch Pharmalabs

      Arch Pharmalabs

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      We are a Pharmaceutical Company aligned across two business verticals viz. Products and Services. Our Products business comprises manufacture and sale of APIs and Intermediates to innovator and generic pharmaceutical players in both Domestic and International markets including the regulated markets.

    • Small logo of Boehringer Ingelheim

      Boehringer Ingelheim

      Manufacturer

      Headquarters

      Flag of GermanyGermany

      Sites

      Flag of GermanyGermany
      Flag of United States of AmericaUnited States of America
      Flag of AustriaAustria

      Regulatory compliance

      EDQM
      KDMF
      JDMF
      GDP
      CEP COS
      USDMF
      NDC API
    • Small logo of Swati Spentose

      Swati Spentose

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      JDMF
      KDMF
      WHO GMP
      EU WC
      NDC API
      USDMF
      CEP COS

      Audit standards

      GMP (APIs)

      Company description

      Swati Spentose (SSPL) is a technology-driven manufacturing company specializing in the production and supply of both APIs & FDFs. Swati Spentose Pvt. Ltd. (SSPL) Unit 1 has been inspected by USFDA, certified by EU-GMP, approved by COFEPRIS in Mexico & MFDS in Korea, and WHO-GMP certified (www.spentose.com). They offer products such as Polysaccharide Block-Pentosan Polysulfate Sodium (PPS), Multipurpose Block-Lidocaine Base/HCl, Meloxicam, Melatonin, Granisetron Base/HCl, Prilocaine Base/HCL, Glycopyrrolate, Tamsulosin, Silodosin, Mirabegron. SSPL Unit-2 details are not provided.

    • Guangzhou Tosun Pharmaceutical

      Headquarters

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

      Company description

      Established in 1999, Guangzhou Tosun Pharmaceutical specializes in the import and export of Active Pharmaceutical Ingredients, Chemical Raw Materials, Intermediates, Excipients, and Herbal Extracts. The company has evolved into a pharmaceutical group enterprise with comprehensive operations in medicine, related products, processing, manufacturing, and international trade, leveraging its substantial economic resources.

    • Small logo of Cosma

      Cosma

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of ItalyItaly

      Sites

      Flag of ItalyItaly

      Regulatory compliance

      GDUFA
      JDMF
      KDMF
      FDA
      USDMF
      NDC API
      CEP COS

      Audit standards

      GMP (APIs)

      Company description

      COSMA S. P. A. (established in 1977) and AMSA S. P. A. (established in 1953) are a pair of chemical facilities widely recognized globally and particularly valued in the occidental world and in the nations that adhere to the Pharmaceutical Inspection Convention (PIC). They are part of the CFM Group, a privately-owned company engaged in the fields of chemistry and pharmaceuticals since 1949

    • Small logo of Shandong Xinhua Pharmaceutical

      Shandong Xinhua 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
      Flag of United States of AmericaUnited States of America

      Regulatory compliance

      EDQM
      FDA
      KDMF
      JDMF
      GDUFA
      GDP
      CEP COS
      NDC API
      USDMF

      Audit standards

      GMP (APIs)

      Company description

      Shandong Xinhua was founded in 1943. After evolving for more than 75 years, it has established 5 manufacturing facilities, spanning an area of over 3 million square meters. The company has set up two international branches and employs over 5000 staff. Its business encompasses API, finished dosage formulation, pharmaceutical intermediates, and pharmaceutical commerce.

    • Small logo of Hrv Global Lifesciences

      Hrv Global Lifesciences

      Headquarters

      Flag of IndiaIndia

      Company description

      HRV Global stands as a prominent producer, vendor & distributor of a diverse array of Active Pharmaceutical Ingredients, Innovative Pharma Intermediates, Pellets, Chemicals of Food Grade, Additives for Food, and Ingredients for Food on a global scale.

    • Small logo of Smilax Laboratories

      Smilax Laboratories

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      JDMF
      WHO GMP
      EDQM
      EU WC
      NDC API
      CEP COS
      USDMF

      Audit standards

      GMP (APIs)

      Company description

      Smilax Laboratories Limited is a leading vertically integrated pharmaceutical organization, manufacturing Active Pharmaceutical Ingredients, API Intermediates and NDDS/Pellets for the generics market across the world. The position today built by Smilax is due to its cutting edge research , world class manufacturing and a truly global supply chain management.

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