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  • Small logo of Dipharma

    Dipharma

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of ItalyItaly

    Sites

    Flag of ItalyItaly

    Regulatory compliance

    EDQM
    KDMF
    JDMF
    FDA
    GDUFA
    USDMF
    NDC API
    CEP COS

    Audit standards

    GMP (APIs)

    Company description

    Dipharma is a global Contract Development and Manufacturing Organisation (CDMO) and a leading manufacturer of Active Pharmaceutical Ingredients, with more than 500 employees, 4 cGMP plants and commercial offices in Italy, U.S.A. and China. We put our heart and soul into supporting our customers with a competitive and highly proactive approach, backed by 75 years of experience in safely handling hazardous chemical processes using state-of-the-art technologies. As a third-generation family-owned company, we have a long history of stability, commitment and financial solidity. We know how to deliver on creative innovation and we understand the critical importance of matching timelines, while operating in full respect of international regulations, Intellectual Property and third-party patents.

  • 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.

  • Malladi Drugs & Pharmaceuticals

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of IndiaIndia

    Sites

    Flag of IndiaIndia
    Flag of PolandPoland
    Flag of United States of AmericaUnited States of America

    Regulatory compliance

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

    Audit standards

    GMP (APIs)

    Company description

    Established in 1980 by microbiologist Mr. M L N Sastry, Malladi Drugs & Pharmaceuticals Ltd quickly emerged as a pioneer in the production of ephedrine and pseudoephedrine salts. Today, it holds a prominent position as a manufacturer of APIs in the cough and cold segment, as well as in therapeutic segments such as antihistamines, anti-convulsants, anti-depressants, and anxiolytics (CNS). With a vast export network spanning approximately 60 countries, the company derives over 85% of its revenue from international markets. Malladi's manufacturing units have received approval from prominent regulatory bodies including the FDA, EDQM, KFDA, and TGA.

  • Small logo of Virupaksha Organics

    Virupaksha Organics

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of IndiaIndia

    Sites

    Flag of IndiaIndia

    Regulatory compliance

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

    Audit standards

    GMP (APIs)

    Company description

    VIRUPAKSHA ORGANICS LIMITED operates as a fully integrated manufacturer of Active Pharmaceutical Ingredients (API’s) and intermediates in Hyderabad, Telangana, India. The company is overseen by professionals from the pharmaceutical industry with over 25 years of expertise. The successful combination of technical knowledge, organizational capabilities, experience, and infrastructure has contributed to the company's achievements and expansion. Established in 2003, the company achieved an impressive turnover of USD 30 million in its 10th year of operation.

  • Small logo of Morepen Laboratories

    Morepen Laboratories

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of IndiaIndia

    Sites

    Flag of IndiaIndia

    Regulatory compliance

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

    Audit standards

    GMP (APIs)

    Company description

    Embarking on a transformative journey over four decades, Morepen has consistently strived to embody an organization marked by discernible, impactful differences. Every action we undertake is imbued with a profound commitment to enrich the lives we touch. Nestled amidst the serene surroundings of Baddi, our cutting-edge manufacturing facility boasts a scientifically integrated complex housing 10 plants, each tailored to produce specific product lines. Driven by a relentless pursuit of innovation, Morepen's extensive research and development infrastructure, alongside our dedicated workforce, ensures the maintenance of stringent quality standards. With a robust global footprint, we export to over 80 countries, holding certifications from esteemed regulatory authorities such as USFDA, WHO GMP, and EU GMP.

  • Wockhardt

    Manufacturer
    Audited
    Audit report available
    Non-Compliance Report

    Headquarters

    Flag of IndiaIndia

    Sites

    Flag of IndiaIndia
    Flag of IrelandIreland
    Flag of United KingdomUnited Kingdom
    Flag of United States of AmericaUnited States of America

    Regulatory compliance

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

    Audit standards

    GMP (APIs)

    Company description

    Wockhardt UK (WUK) operates as a diverse pharmaceutical company, serving as a significant provider of healthcare products to the NHS through hospitals, multiple retail pharmacy chains, and wholesalers. It is currently experiencing an exciting period with thriving export and contract manufacturing divisions. Leveraging the global strength, research base, and impressive product pipeline of its parent company, Wockhardt UK is well-positioned for future growth.

  • Small logo of Seqens

    Seqens

    Manufacturer

    Headquarters

    Flag of FranceFrance

    Sites

    Flag of FranceFrance
    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 Ind Swift Laboratories

    Ind Swift Laboratories

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of IndiaIndia

    Sites

    Flag of IndiaIndia
    Flag of ItalyItaly

    Regulatory compliance

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

    Audit standards

    GMP (APIs)

    Company description

    Headquartered in Chandigarh, India, Ind-Swift Laboratories Ltd. today is a global manufacturer of APIs, Intermediates, and formulations (through group collaboration). With regulated 6+ manufacturing sites (including 2 group subsidiaries) in Punjab and Jammu, we cater to the API needs of regulated markets including USFDA, EDQM, PMDA, ANVISA, EU-GMP, KFDA, NMO, ANSM, Cofepris, TGA, WHO, ROW. Today, Ind-Swift Laboratories Ltd. is a significant player in manufacturing APIs towards Cardiovascular health, Antihistamine, Antidiabetic, Antipsychotic, Antimigraine, Parkinson’s Disease, Antineoplastic, ADHD Symptoms, Analgesics, Alcohol Abstinence and Bone Resorption Inhibitor. We also hold global leadership positions in the Macrolide Antibiotic segment.

  • 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 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 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

  • 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 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 Vasudha Pharma Chem

    Vasudha Pharma Chem

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of IndiaIndia

    Sites

    Flag of IndiaIndia

    Regulatory compliance

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

    Audit standards

    GMP (APIs)

    Company description

    The organization is engaged in the production of API’s, Intermediates, and semi-processed formulations. Its manufacturing facilities have been inspected by global regulatory authorities such as USFDA, EDQM, PMDA, KFDA & Cofepris (Mexican MOH). The products are shipped worldwide and have a strong presence in regulated markets including the USA, Japan & Europe etc. It operates six manufacturing facilities situated in Andhra Pradesh & Telangana, with an annual turnover of 100 Million USD. The company's credit rating has been improved by ‘India Ratings Pvt. Ltd. (100% subsidiary of Fitch).

  • 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 Sumitomo Pharma

    Sumitomo Pharma

    Manufacturer

    Headquarters

    Flag of JapanJapan

    Sites

    Flag of JapanJapan

    Regulatory compliance

    FDA
    KDMF
    EDQM
    GDUFA
    USDMF
    JDMF
    CEP COS
    NDC API

    Company description

    Our Mission is "To contribute broadly to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide." By channeling efforts into the research and development of new drugs, Sumitomo Pharma aims to realize this Mission and provide innovative and useful pharmaceuticals and healthcare solutions to people in Japan and around the world.

  • 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

  • Ranbaxy Laboratories

    Manufacturer
    Non-Compliance Report

    Headquarters

    Flag of IndiaIndia

    Sites

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

    Regulatory compliance

    EDQM
    WHO GMP
    JDMF
    EU WC
    FDA
    GDUFA
    USDMF
    CEP COS
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