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    Glimepiride

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    59results for glimepiride

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    • Small logo of Sanofi

      Sanofi

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of FranceFrance

      Sites

      Flag of FranceFrance
      Flag of GermanyGermany
      Flag of SingaporeSingapore
      Flag of TürkiyeTürkiye
      Flag of BrazilBrazil
      Flag of HungaryHungary
      Flag of United States of AmericaUnited States of America

      Regulatory compliance

      EDQM
      WHO GMP
      KDMF
      JDMF
      GDP
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (Finished Dosage)
      GMP (APIs)
      GDP (Distribution)

      Company description

      Sanofi is a global healthcare leader committed to improving lives around the world. With a strong focus on research and development, Sanofi strives to transform scientific innovation into healthcare solutions that address unmet medical needs. The company's extensive portfolio spans prescription medicines, vaccines, consumer healthcare products, and biopharmaceuticals, covering a wide range of therapeutic areas, including diabetes, cardiovascular disease, oncology, immunology, rare diseases, and vaccines.

    • Chongqing Carelife 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
      FDA
      JDMF
      GDUFA
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (APIs)
    • 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 Rakshit Drugs

      Rakshit Drugs

      Manufacturer
      Audited
      Audit report available

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      EU WC
      KDMF
      JDMF
      CEP COS
      NDC API

      Audit standards

      GMP (APIs)

      Company description

      Rakshit Corporation, has a long-standing presence in the field of API production, operating for more than 20 years and possessing facilities that are sanctioned by USFDA, Japan-PMDA, Korean FDA, and multiple approved CEPs. Rakshit stands as the primary global producer of Sildenafil Citrate API and its intermediates, specializing in the production of Erectile Dysfunction APIs. The Rakshit conglomerate is equipped with three manufacturing units that comply with cGMP standards.

    • Enaltec Labs

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (Subcontracted Laboratory)

      Company description

      Enaltec was established in 2006 by a group of young and experienced professionals with the specific objective to develop and produce complex, small volume, technology-driven products at competitive prices, thus providing the critical India advantage to generic formulators across the world.

    • 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 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 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.

    • 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 Euroapi

      Euroapi

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of FranceFrance

      Sites

      Flag of FranceFrance
      Flag of HungaryHungary
      Flag of GermanyGermany
      Flag of United KingdomUnited Kingdom
      Flag of ItalyItaly
      Flag of SlovakiaSlovakia

      Regulatory compliance

      EDQM
      GDUFA
      KDMF
      JDMF
      FDA
      CEP COS
      USDMF
      NDC API

      Audit standards

      GMP (APIs)

      Company description

      Euroapi focuses on revolutionizing active component solutions to sustainably fulfill the demands of clients and patients globally. As a prominent figure in active pharmaceutical ingredients, we possess a comprehensive portfolio of around 200 products, encompassing a wide range of technologies, and are constantly developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO). Our 3,350 employees are driven by the commitment to improving access to essential therapies and promoting health

    • 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 Dishman Carbogen Amcis

      Dishman Carbogen Amcis

      Manufacturer
      Audited
      Non-Compliance Report

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of NetherlandsNetherlands
      Flag of SwitzerlandSwitzerland
      Flag of FranceFrance

      Regulatory compliance

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

      Company description

      For more than three decades, we have been providing support to the pharmaceutical and biopharmaceutical sectors in the development of medications. Our aim is to aid our clients in the creation and introduction of new drugs to the market, ultimately enhancing the well-being of patients globally. We are dedicated to assisting our partners in producing and manufacturing intricate and demanding compounds, highly active ingredients, and pioneering advancements in vitamin, healthcare, and industrial products with the goal of making the world a better place.

    • Small logo of Recipharm

      Recipharm

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of SwedenSweden

      Sites

      Flag of ItalyItaly
      Flag of FranceFrance
      Flag of SwedenSweden
      Flag of GermanyGermany
      Flag of SpainSpain
      Flag of United KingdomUnited Kingdom
      Flag of IndiaIndia

      Regulatory compliance

      EDQM
      FDA
      KDMF
      JDMF
      GDUFA
      GDP
      CEP COS
      NDC API
      USDMF

      Audit standards

      GMP (APIs)

      Company description

      Recipharm is an experienced, global CDMO dedicated to meeting your evolving needs through operational excellence, scientific know-how and customer connectivity. Our worldwide reach, localised market knowledge and ever-expanding alliance of expertise allow us to anticipate your needs and provide tailored, reliable services to consistently deliver on time and in full.

    • 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 Indoco Remedies

      Indoco Remedies

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)
      GMP (Finished Dosage)

      Company description

      Indoco Remedies Limited, based in India, is an emerging, fully integrated, research-oriented pharmaceutical firm with a global presence. We manufacture a diverse range of cost-effective, high-quality products in various therapeutic sectors that are widely embraced by healthcare professionals and clients across the globe. The company boasts a robust production infrastructure, a focus on Research & Development, and is uniquely positioned as a preferred collaborator providing comprehensive solutions to pharmaceutical companies marketing generics

    • Small logo of Medichem

      Medichem

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of SpainSpain

      Sites

      Flag of SpainSpain
      Flag of MaltaMalta

      Regulatory compliance

      EDQM
      JDMF
      KDMF
      FDA
      GDUFA
      GDP
      NDC API
      USDMF
      CEP COS

      Audit standards

      GMP (APIs)

      Company description

      Medichem is a vertically integrated pharmaceutical company. We specialize in the development and manufacture of APIs and FDFs for the global generics industry. Our portfolio includes around 45 APIs and 20 FDFs, and we are a world leader in Chlorhexidine products. With nearly half a century of industry experience, we guarantee the highest standards of quality, operational excellence and respect for the environment. Medichem is headquartered in Spain, with a team of around 400 talented individuals in locations including the USA, Malta and China. We serve over 600 corporate customers in more than 60 countries worldwide.

    • Small logo of Glenmark Life Sciences

      Glenmark Life Sciences

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      KDMF
      JDMF
      EU WC
      NDC API
      CEP COS
      USDMF

      Audit standards

      GMP (APIs)

      Company description

      Glenmark Life Sciences Limited is a prominent producer and developer of specialized, high-value, non-generic, active pharmaceutical ingredients (APIs) within chronic therapeutic fields such as heart disease, disorders of the central nervous system, pain management, and diabetes. The corporation is progressively offering CDMO services to various multinational and specialized pharmaceutical firms. It maintains a varied collection of over 137 compounds and delivers its merchandise to clients in India, Europe, North America, Latin America, Japan, and other parts of the globe (ROW).

    • 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

    • Small logo of Shenzhen Haorui

      Shenzhen Haorui

      Manufacturer

      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
      FDA
      GDUFA
      CEP COS
      USDMF
      KDMF
      NDC API
      JDMF

      Company description

      Haorui, established in the year 1997, operates as a manufacturer and provider of APIs, pharmaceutical intermediates, veterinary products, and food additives. Furthermore, it aids international pharmaceutical firms in achieving domestic registration for their finished dosage forms to support their global expansion efforts. The company's array of USFDA approved products includes Flumazenil, Granisetron HCl, Granisetron Base, Docetaxel Anhydrous, Irinotecan HCl, and Dasatinib Monohydrate among others. Its headquarters is situated in Shenzhen, China, while it maintains four manufacturing sites in Hubei, Zhejiang, Jiangxi, and Henan. The Hubei facility is recognized for its USFDA and EU GMP approvals, specializing in the production of high potency and oncology materials within a dedicated oncology workshop, meeting OEB 5 material production standards. Haorui prides itself as a dependable partner for all your pharmaceutical needs.

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