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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 Lupin

    Lupin

    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 United KingdomUnited Kingdom

    Regulatory compliance

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

    Audit standards

    GMP (APIs)

    Company description

    Headquartered in Mumbai, India, Lupin is a global pharmaceutical leader with a footprint across the U.S., LATAM, APAC, EMEA and India, with products distributed in over 100 markets. With a diverse portfolio of over 1,200 products, Lupin remains committed to its mission of making quality healthcare accessible to the communities we serve. Our visionary Founder, Dr. Desh Bandhu Gupta, instilled in us the importance of offering quality, affordable and innovative medicines and being a responsible corporate citizen, making a positive difference to patients, communities and the environment.

  • 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 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 Arevipharma

    Arevipharma

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of GermanyGermany

    Sites

    Flag of GermanyGermany

    Regulatory compliance

    EDQM
    JDMF
    KDMF
    GDUFA
    FDA
    CEP COS
    USDMF
    NDC API

    Audit standards

    GMP (APIs)

    Company description

    Arevipharma is a modern manufacturer of active pharmaceutical ingredients and complex fine chemicals. With our products, we contribute to the health of millions of people on all continents. We are manufacturing health!

  • Small logo of Koçak Farma İlaç ve Kimya Sanayi A.Ş.

    Koçak Farma İlaç ve Kimya Sanayi A.Ş.

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of TürkiyeTürkiye

    Sites

    Flag of TürkiyeTürkiye

    Audit standards

    GMP (Finished Dosage)

    Company description

    Being established in 1971, Koçak Pharmaceuticals has became one of the most prominent companies of Turkish Pharma Sector in the past 53 years. Today with almost 2000 employees, over 600 different type of products and both API and finished product production; Koçak has became an important contributor to Turkish medicine. The headquarters of Koçak Farma is located in İstanbul, there are 11 regional offices and the "Sales Force" consists of approximately 400 employees. In 2000, the firm has moved production facilities to Çerkezköy Organized Industrial Zone, to a newly constructed 140.000m2 production plant. It has 100.000 indoor area. Raw materials and pharmaceuticals are produced in 2 different factories. We produce pharmaceuticals targeting many areas of medicine, specifically focusing on gynecology &obstetrics, urology, chest diseases (tuberculosis), cardiology, oncology and products of general health protection. Koçak Farma has been exporting API and finished products to several countries and has been contract manufacturing for local and international companies. The vision of Koçak Farma is to share its experience and technology with new partners by contract manufacturing or export activities.

  • 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 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 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 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 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 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 Fareva

    Fareva

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of FranceFrance

    Sites

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

    Regulatory compliance

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

    Audit standards

    GMP (Finished Dosage)

    Company description

    FAREVA stands as a prominent global pharmaceutical CDMO with leading expertise in the development and production of a wide variety of Drug Products and Active Pharmaceutical Ingredients (APIs). The company has a workforce of 13,000 individuals spread across 41 manufacturing facilities situated in 13 countries across EMEA and the Americas. Among these facilities, 18 are exclusively dedicated to pharmaceutical operations. FAREVA’s API division carries out its activities in 3 European locations situated in France and Germany.

  • 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 USV

    USV

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of IndiaIndia

    Sites

    Flag of IndiaIndia

    Regulatory compliance

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

    Audit standards

    GMP (Finished Dosage)

    Company description

    USV is a 60-year-old organization headquartered in Mumbai, generating approximately US$ 500 million in revenue, primarily from the Diabetic and Cardiac sectors. It is one of the top 15 companies in India, operating in over 60 countries and serving more than 100 satisfied customers with exports totaling around US$ 100 million. With 100+ product approvals globally and 30+ DMF submissions worldwide, USV provides value-added products in Oral Solids, Injectables (PFS, Vials), Ophthalmics, Biosimilars (Pegfilgrastim), and Peptides.

  • Small logo of Aarti Pharmalabs

    Aarti Pharmalabs

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of IndiaIndia

    Sites

    Flag of IndiaIndia

    Regulatory compliance

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

    Audit standards

    GMP (APIs)

    Company description

    Aarti Pharmalabs Limited, also known as APL, is a prominent Indian producer of Pharmaceuticals and Nutraceuticals with an international presence. Our product range includes Generic APIs, Intermediates, and Xanthine derivatives such as Caffeine. We specialize in providing CDMO services for small molecule drug substances, focusing on process development and manufacturing for both clinical and commercial phase projects intended for Innovator companies. Additionally, we have specialized facilities dedicated to the manufacturing of HPAPIs, Corticosteroids, and Cytotoxic and Oncology products.

  • Small logo of Sumitomo Pharma

    Sumitomo Pharma

    Manufacturer

    Headquarters

    Flag of JapanJapan

    Sites

    Flag of JapanJapan

    Regulatory compliance

    FDA
    KDMF
    EDQM
    GDUFA
    USDMF
    JDMF
    CEP COS
    NDC API

    Company description

    Our Mission is "To contribute broadly to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide." By channeling efforts into the research and development of new drugs, Sumitomo Pharma aims to realize this Mission and provide innovative and useful pharmaceuticals and healthcare solutions to people in Japan and around the world.

  • Small logo of Mac-Chem Products

    Mac-Chem Products

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of IndiaIndia

    Sites

    Flag of IndiaIndia

    Regulatory compliance

    EDQM
    EU WC
    WHO GMP
    KDMF
    FDA
    USDMF
    CEP COS

    Audit standards

    GMP (APIs)

    Company description

    Mac-Chem has a National and Global footprint with a wide presence across the globe. Mac-Chem has carved a niche for itself in the exceedingly competitive and quality conscious sphere of Active Pharmaceutical Ingredients (API) manufacturing with US-FDA, EDQM, COFEPRIS, ANVISA, MFDS-Korea, WHO-GMP and ISO certified facilities

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