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    Esomeprazole magnesium

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    83results for esomeprazole magnesium

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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 Aurobindo Pharma

      Aurobindo Pharma

      Manufacturer
      Audited
      Audit report available
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      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 Minakem

      Minakem

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of FranceFrance

      Sites

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      Regulatory compliance

      EDQM
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      JDMF
      KDMF
      GDUFA
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (APIs)
      GMP (Excipients)

      Company description

      Minakem is a fully integrated commercial manufacturer of Active Pharmaceutical Ingredients (APIs) with R&D capabilities to develop and transfer the manufacturing process to one of its four API facilities in Europe or Canada

    • 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 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 Zydus Lifesciences

      Zydus Lifesciences

      Manufacturer
      Audited
      Audit report available
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      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.

    • Credo Life Sciences

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Company description

      Credo Life stands as one of the foremost producers and suppliers of Specialized Pellet and Taste Mask Granules / DC Granules situated in Hyderabad, India. The organization's principles are anchored in trustworthiness, dedication, excellence, and punctual delivery.

    • 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 Seqens

      Seqens

      Manufacturer

      Headquarters

      Flag of FranceFrance

      Sites

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      Flag of FinlandFinland
      Flag of GermanyGermany
      Flag of ThailandThailand
      Flag of IsraelIsrael
      Flag of United States of AmericaUnited States of America
      Flag of People's Republic of ChinaPeople's Republic of China

      Regulatory compliance

      EDQM
      FDA
      KDMF
      JDMF
      GDUFA
      USDMF
      NDC API
      CEP COS
    • 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 Kalintis Healthcare

      Kalintis Healthcare

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      NDC API
      USDMF

      Audit standards

      GMP (APIs)

      Company description

      Kalintis Healthcare envisions creating a health-conscious Pharmaceuticals Company focused on promoting Wellness for Humanity. The company employs advanced in-house technology to maintain high quality standards in the manufacturing of Speciality Chemicals, Advanced Intermediates, and Active Pharmaceutical Ingredients through Chemical Process R&D, followed by commercial-scale production to cater to global customers. The APIs produced are intended for the USA market, while all other products are targeted for international distribution. There are plans to submit at least three DMF filings annually.

    • 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 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 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 Glenmark Pharmaceuticals

      Glenmark Pharmaceuticals

      Manufacturer
      Warning letter

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of United States of AmericaUnited States of America
      Flag of ArgentinaArgentina

      Regulatory compliance

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

      Company description

      Glenmark Pharmaceuticals Limited is a global pharmaceutical company based in Mumbai, India. The company focuses on developing and manufacturing generic and innovative drugs. Their therapeutic areas of expertise include dermatology, respiratory, and oncology. They also manufacture high-quality affordable generic products for the US and European markets through Glenmark Life Sciences, an independent unit of Glenmark Pharmaceuticals.

    • 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.

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