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    • 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 Apotex

      Apotex

      Manufacturer

      Headquarters

      Flag of CanadaCanada

      Sites

      Flag of CanadaCanada
      Flag of NetherlandsNetherlands
      Flag of BahamasBahamas
      Flag of IndiaIndia
      Flag of SwitzerlandSwitzerland
      Flag of MexicoMexico
      Flag of BelgiumBelgium

      Regulatory compliance

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

      Company description

      For more than 40 years, Apotex has been a reputable name in the Canadian pharmaceutical industry, offering patients increased availability to high-quality, cost-effective medications

    • 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.

    • Optimus Drugs Pvt Ltd.

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      GDUFA
      EU WC
      WHO GMP
      KDMF
      USDMF
      NDC API
      CEP COS

      Audit standards

      GMP (APIs)

      Company description

      Optimus is one of the fastest-growing pharmaceutical companies with 16 years of experience in providing the best quality of API, Intermediates & Finished formulations in Global markets. Our aim from day one has been to provide and ensure better healthcare across the globe through our research, Innovations, affordable products & manufacturing excellence. Sekhmet Pharmaventures acquired major stake in Optimus Drugs Group of Companies in May 2022.

    • Small logo of Pfizer

      Pfizer

      Manufacturer
      Audited
      Warning letter

      Headquarters

      Flag of United States of AmericaUnited States of America

      Sites

      Flag of IndiaIndia
      Flag of United States of AmericaUnited States of America
      Flag of IrelandIreland
      Flag of SingaporeSingapore
      Flag of BelgiumBelgium
      Flag of ItalyItaly
      Flag of Puerto RicoPuerto Rico
      Flag of People's Republic of ChinaPeople's Republic of China
      Flag of CanadaCanada
      Flag of GermanyGermany

      Regulatory compliance

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

      Company description

      Pfizer CentreOne® is a completely distinct global contract development and manufacturing organization (CDMO), as well as a prominent provider of specialty APIs and intermediates. Supported by resources from Pfizer, we have provided technical knowledge, regulatory assistance, and long-term supply for more than 40 years. With a network of over 35 sites spanning six continents, we are capable of securely and effectively guiding complex compounds from development to commercial manufacture. For more details, please visit http://www.pfizercentreone.com

    • 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.

    • 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 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 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 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.

    • Nosch Labs

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      EDQM
      EU WC
      KDMF
      JDMF
      CEP COS
      USDMF

      Audit standards

      GMP (APIs)
      GMP (Finished Dosage)

      Company description

      Dream that drives us at Nosch. The laudable goal that we aim for. The vision that suffuses us with the passion to innovate and excel. Over the past twenty one years, we have been ceaselessly engaged in a quest to sustain and improve the quality of life through creating safe pharmaceutical solutions. Our competencies have grown to embrace the entire pharmaceutical value chain-APIs and semi-finished Formulations. Today, with an impeccable reputation for uncompromising quality and timely delivery, Nosch has emerged as the partner of choice across the world.

    • Small logo of Neuland Laboratories

      Neuland Laboratories

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      Established in 1984, Neuland Laboratories Limited is a publicly traded company based in Hyderabad, India. The organization offers solutions throughout the entire range of the pharmaceutical industry's chemical needs, from synthesizing library compounds to providing NCEs and advanced intermediates at different stages in the clinical life cycle, as well as for commercial launch. Neuland's specialty lies in the production of APIs and advanced intermediates from its facilities approved by the USFDA. Its primary expertise is the application of effective process chemistry to manufacturing in a compliant regulatory setting.

    • Small logo of Jubilant Ingrevia

      Jubilant Ingrevia

      Manufacturer

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of United States of AmericaUnited States of America
      Flag of CanadaCanada

      Regulatory compliance

      GDUFA
      EU WC
      WHO GMP
      FDA
      EDQM
      USDMF
      NDC API

      Company description

      Jubilant Ingrevia Limited is an internationally integrated provider of Life Science products and Innovative Solutions, catering to Pharmaceutical, Nutrition, Agrochemical, Consumer, and Industrial clients with tailored products and solutions that are pioneering, cost-efficient, and adhere to outstanding quality standards. Its range also encompasses personalized research and production for pharmaceutical and agrochemical customers on an exclusive basis. The organization provides a selection of over 125 products & pioneering solutions utilizing more than 35 essential chemistry and technology platforms across its three business segments of Speciality Chemicals, Nutrition & Health Solutions, and Chemical Intermediates. With a team of over 2,100 employees serving more than 1,500 customers in over 50 countries worldwide, the company is motivated to bring value to millions of lives through innovations and state-of-the-art technology. For more information, please visit www.jubilantingrevia.com. Business Segments: Speciality Chemicals consists of distinct building blocks such as Pyridine and Picolines, Cyanopyridines, Piperidine, and their value-added derivatives. The company has recently ventured into Diketene Chemistry, currently producing Diketene esters & amide with several other Diketene derivatives in the pipeline. The Speciality Chemicals products are utilized in the production of a variety of Agrochemicals, Pharmaceuticals, Nutrition, Fine chemicals, Oilfield chemicals, Electronics, and Solvents. Nutrition & Health Solutions caters to Human & Animal Nutrition, Pharmaceutical & Personal Care segment/applications and comprises three businesses - Nutrition & Health Ingredients, Animal Nutrition & Health Solutions, and Human Nutrition & Health Solutions. Chemical Intermediates manufactures a range of Chemical Intermediates including Acetyl Products and Speciality Ethanol.

    • Small logo of Gland Pharma

      Gland Pharma

      Manufacturer
      Audited

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      EDQM
      WHO GMP
      GDUFA
      EU WC
      KDMF
      FDA
      USDMF
      CEP COS

      Company description

      Established in 1978 as a specialized facility for Small Volume Parenterals (SVPs), Gland Pharma has evolved into a forward-thinking and quality-focused organization catering to the pharmaceutical requirements of diverse global markets. The company possesses state-of-the-art facilities for injectables established in partnership with Vetter Group, Germany, providing Gland Pharma a technological advantage in injectables, particularly in Pre Filled Syringes.

    • Small logo of SMS Pharmaceuticals

      SMS Pharmaceuticals

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      SMS Lifesciences India Limited, headquartered in Hyderabad, India, is a research-driven company with over three decades of experience. It is a public listed leading API manufacturer, supplying to major generic and innovator firms. With a focus on APIs, the company operates four state-of-the-art facilities and provides quality alternative manufacturing solutions to multinational companies for their contract research and manufacturing needs. The company has multiple manufacturing facilities supporting a wide range and capacity of APIs and Intermediates.

    • Small logo of Symed Labs

      Symed Labs

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      EU WC
      KDMF
      FDA
      EDQM
      GDUFA
      CEP COS
      NDC API
      USDMF

      Audit standards

      GMP (APIs)

      Company description

      Situated in Hyderabad, India, Symed Labs Ltd is a prominent and innovative producer of Active Pharmaceutical Ingredients (APIs) & a comprehensive solution provider for the pharmaceutical sector for chemistry related services. Symed labs has autonomously created processes for more than fifty APIs across various therapeutic categories in the laboratory and upscaled them to plant, as well as vending them to over 600 clients in 30 nations in the regulated and less regulated markets

    • 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 Jubilant Generics

      Jubilant Generics

      Manufacturer
      Warning letter

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Company description

      We are a global vertically integrated pharmaceutical company engaged in research and development, manufacture, sale and distribution of prescription and OTC pharmaceutical products, with global presence in more than 50 countries, including United States, Europe, Canada, Japan, Australia and Rest of the World. We offer a wide range of proprietary finished dosage formulation catering to different therapeutic segments, including CVS, CNS, gastro-intestinal, etc. in multiple dosage forms including: Immediate-release oral solids Modified release oral solids MUPS based products Chewable tablets Powder for oral solutions & Suspensions

    • Small logo of Akums Drugs & Pharmaceuticals

      Akums Drugs & Pharmaceuticals

      Manufacturer
      Non-Compliance Report

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Company description

      Akums is a research-oriented, fully integrated firm specializing in the production, manufacturing, and distribution of APIs and intermediates. Akums has positioned itself as a top manufacturer of generic pharmaceuticals based in India, serving customers in more than 51 nations. It operates a dedicated facility for personalized research and synthesis. Akums' production units are located at three different sites in two states of India. Its strict protocols and processes guarantee compliance with all regulatory standards, environmental norms, and technological advancements. Akums holds certifications from EU-GMP, KFDA, WHO-GMP, and PMDA.

    • 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).

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