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    • S.B. Pharma GmbH

      Headquarters

      Flag of GermanyGermany

      Sites

      Flag of GermanyGermany

      Company description

      An organization named SB Pharma GmbH, located in Cologne, is a prominent firm with the aim of providing pharmaceuticals, medical products, medical devices, and a diverse range of other healthcare products. They focus on ensuring a consistent supply of both traditional and innovative medicines to hospitals and the general population, thus contributing to the long-term enhancement of the quality of life in numerous nations.

    • 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.

    • Small logo of Bausch Health

      Bausch Health

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of CanadaCanada

      Sites

      Flag of CanadaCanada
      Flag of South KoreaSouth Korea
      Flag of United States of AmericaUnited States of America
      Flag of PolandPoland
      Flag of IrelandIreland

      Regulatory compliance

      EDQM
      KDMF
      FDA
      GDUFA
      GDP
      USDMF

      Audit standards

      GMP (Finished Dosage)

      Company description

      Bausch Health is focused on improving people’s lives through our health care products. We are committed to patients, health care providers, other stakeholders and society, as we build an innovative company dedicated to advancing global health. We are known for the quality of our products in dermatology, in cardiovascular-metabolic and in eye health. We manufacture and market a broad range of health care products, including branded and generic pharmaceuticals, over-the-counter (OTC) products and medical devices (contact lenses, intraocular lenses, ophthalmic surgical equipment and aesthetic devices) directly or indirectly in more than 90 countries and regions, including the United States, Canada, Europe, the Middle East, Africa, Asia Pacific and Latin America. Each day, our products are used by up to 150 million people 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.

    • 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 Merck Group

      Merck Group

      Manufacturer
      Audited

      Headquarters

      Flag of GermanyGermany

      Sites

      Flag of FranceFrance
      Flag of SwitzerlandSwitzerland
      Flag of SpainSpain
      Flag of People's Republic of ChinaPeople's Republic of China
      Flag of United States of AmericaUnited States of America
      Flag of GermanyGermany
      Flag of MexicoMexico
      Flag of PolandPoland
      Flag of ItalyItaly
      Flag of United KingdomUnited Kingdom
      Flag of IsraelIsrael
      Flag of IrelandIreland
      Flag of AustriaAustria

      Regulatory compliance

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

      Company description

      Established in Darmstadt, Germany in 1668 by Friedrich Jacob Merck, Merck KGaA stands as the oldest pharmaceutical and chemical corporation globally. It is renowned for its pioneering and high-quality advanced products in the fields of healthcare, life science, and performance materials. Internationally, the company is recognized as Merck, while operating as EMD Serono in the Biopharma sector, as MilliporeSigma in the Life Science sector, and as EMD Performance Materials in the materials sector in the United States and Canada.

    • 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 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.

    • 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.

    • Small logo of Harman Finochem

      Harman Finochem

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      Harman Finochem Limited is an India-based Pharmaceutical Company catering to its clients across the globe. Established by Mr. Bhupinder Singh Manhas in 1983, our core competencies are in manufacturing and exporting of Active Pharmaceutical Ingredients mainly Metformin HCl, Fenofibrate, Divalproex Sodium, Riboflavin Phosphate Sodium, Glycopyrrolate/Glycopyrronium bromide and more.

    • 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 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.

    • Small logo of Summit Pharmaceuticals Europe

      Summit Pharmaceuticals Europe

      Audited
      Audit report available

      Headquarters

      Flag of ItalyItaly

      Sites

      Flag of GermanyGermany

      Audit standards

      ISO 9001

      Company description

      Summit Pharmaceuticals Europe S.r.l. (SPE) forms part of Sumitomo Corporation, a Japanese trading and investment company. Operating in Europe, SPE focuses on serving the chemical-pharma industries. Our offerings encompass a wide range of services, intermediates, and APIs, extending to finished dosage forms. Leveraging our extensive network, we provide support for your business expansion into new markets. For additional details, visit www.summipharmaeurope.com and https://www.youtube.com/channel/UCbwT6cHHr4gVrAgwmaImfOQ

    • Wanbury

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      Wanbury Limited, one of India’s fastest growing pharmaceutical companies amongst the ‘Top 50 Companies’ in India (as per ORG-IMS), has a strong presence in API global market and domestic branded Formulation. Wanbury’s major trust area lies in Active Pharmaceutical Ingredient (API) Sales & Marketing in over 50 countries and Pan-India Formulation presence.

    • Virchow Group

      Manufacturer
      Audited

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Company description

      The Virchow Group, situated in the city of Hyderabad, India, is a producer of Active Pharmaceutical Ingredients and finalized formulations. This renowned organization is the largest global manufacturer of Sulfamethoxazole and Ranitidine APIs and has obtained cGMP approval from the US FDA as well as CEP certification from EDQM for these APIs. Additionally, the Virchow Group is a prominent manufacturer of Cephalosporins APIs such as Cefixime, Cefdinir, Cefprozil, Cefpodoxime Proxetil, Cefuroxime Axetil, and Cefditoren Pivoxil, along with other Sulfa drugs like Sulfanilamide and Sulfapyridine, as well as intermediates including Cis-Lactam, GCLE, 7-AVNA, and 7-APCA. They also produce finished dosages.

    • Small logo of Iol Chemicals and Pharmaceuticals

      Iol Chemicals and Pharmaceuticals

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      To help you reach your next business goal, we live our values in everything we do, provide premium service at every step, and always put people first. Putting people first at every step, IOL Chemicals and Pharmaceuticals Limited is a purpose and service-driven Active Pharma Ingredients (API) Products, Intermediates and Specialty Chemicals Company. Driven by principles of excellence, successful innovation and global leadership, IOL Chemicals and Pharmaceuticals Limited is one of the best pharmaceuticals and specialty chemical companies across the globe built on a prolific history of progress and expansion over three decades. Built on a strong foundation of trust, reliability, vision, and partnership, we galvanize our workers into thinking bigger and aiming higher. Our expanding product portfolio will provide a hands-on, realistic solution to today’s healthcare problems. Today, IOL Chemicals and Pharmaceuticals Limited as emerged as the best pharma API manufacturing company because we invest in people, experience and passion.

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