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  • 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 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 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 Erregierre

    Erregierre

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of ItalyItaly

    Sites

    Flag of ItalyItaly

    Regulatory compliance

    KDMF
    JDMF
    GDUFA
    FDA
    EDQM
    USDMF
    CEP COS
    NDC API

    Audit standards

    GMP (APIs)

    Company description

    Erregierre, with its two manufacturing facilities, one situated in San Paolo D'Argon (Bergamo) and the other in Sovere (Bergamo), is a privately owned independent company from Italy established in 1974. It is a leading producer of pharmaceutical active components created through synthesis and distributed globally. Erregierre has undergone inspection by the FDA and is deeply dedicated to manufacturing in strict compliance with cGMPs and the highest global quality standards.

  • Small logo of Aarti Drugs

    Aarti Drugs

    Manufacturer
    Audited
    Audit report available
    Non-Compliance Report

    Headquarters

    Flag of IndiaIndia

    Sites

    Flag of IndiaIndia

    Regulatory compliance

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

    Audit standards

    GMP (APIs)

    Company description

    Aarti Drugs Ltd (ADL) is a part of the Aarti Group of Industries, which has a total worth of USD 500 million. It was established in 1984 and has since developed a strong presence in the fields of Anti-diarrhea and Anti-inflammatory therapeutic groups. The company's manufacturing facilities are located in Tarapur and Sarigam, where it produces a variety of medicines including Vitamins, Anti-arthritis, Anti-fungal, Antibiotics, ACE inhibitors, anti-diabetic, anti-cholinergic, sedatives, and anti-depressant drugs. Over the years, ADL has successfully carved a niche for itself and is now planning to increase its production capacity.

  • 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.

  • Tianjin Tianyao Pharmaceuticals

    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
    FDA
    GDUFA
    NDC API
    CEP COS
    USDMF
    JDMF

    Audit standards

    GMP (APIs)

    Company description

    TIANJIN PHARMACEUTICAL HOLDINGS CO., LTD. advocates the corporate core values of "Love, Integrity and Power", and has been working to improve people's health and well-being, protect people's lives, benefit the public and safeguard people's happy life, and is committed to building a market-driven, technology-empowered leader in the health industry.

  • 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 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 Alembic Pharmaceuticals

    Alembic Pharmaceuticals

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of IndiaIndia

    Sites

    Flag of IndiaIndia

    Regulatory compliance

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

    Audit standards

    GMP (APIs)

    Company description

    Alembic Pharmaceuticals Limited is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities. Headquartered in Vadodara, Gujarat, we derive a third of our revenue of over $600 million from the India market.

  • Interquim

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of SpainSpain

    Sites

    Flag of SpainSpain
    Flag of MexicoMexico

    Regulatory compliance

    EDQM
    JDMF
    KDMF
    FDA
    GDUFA
    NDC API
    USDMF
    CEP COS

    Audit standards

    GMP (APIs)

    Company description

    Ferrer researches, develops, manufactures and commercializes active pharmaceutical ingredients for the pharmaceutical industry under the brand name of Interquim. Our business is based on developing highly competitive processes for the manufacture of high added-value active pharmaceutical ingredients that meet the strictest quality specifications. Through our growing international presence, our products are exported to the largest regulated pharmaceutical markets.

  • 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 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 Amoli Organics

    Amoli Organics

    Manufacturer
    Audited
    Audit report available
    Non-Compliance Report

    Headquarters

    Flag of IndiaIndia

    Sites

    Flag of IndiaIndia

    Regulatory compliance

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

    Audit standards

    GMP (APIs)

    Company description

    Amoli has been working collaboratively with some of the leading global healthcare players since 3 decades. Our strength comes from our expertise in process chemistry further bolstered by our EDQM and USFDA approved facilities allowing us to cater to the needs of the pharmaceutical industry globally. We offer APIs from a wide range of therapeutic classes like NSAIDS, Antifungals, Antidepressants, Hypolipidemics etc. With the support our state-of-the-art R&D centre, we are constantly expanding our product range and foraying into newer therapeutic categories.

  • Titan Laboratories

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of IndiaIndia

    Sites

    Flag of IndiaIndia

    Regulatory compliance

    WHO GMP
    EU WC
    KDMF
    EDQM

    Audit standards

    GMP (Finished Dosage)

    Company description

    Since our inception in 2006, Titan Laboratories has focused on formulating new-age solutions in diversified spectrums of Pellets, Granules, Tablets and Capsule manufacturing. With the expertise of such widespread specialties, we at Titan Laboratories take great pride in our proficiency in providing Quality Analytical Services that focus on the formulation & packaging of both solid and semi-solid finished products. Backed by our holistic approach towards catering to multifarious integrated services, we aim to meet the concept-to-commercialization needs of our customers while providing quality pellets, granules or finish formulations.

  • 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.

  • 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)
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