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    • Small logo of Bioindustria Laboratorio Italiano Medicinali S.p.A.

      Bioindustria Laboratorio Italiano Medicinali S.p.A.

      Manufacturer
      Audited
      Audit report available
      Non-Compliance Report

      Headquarters

      Flag of ItalyItaly

      Sites

      Flag of ItalyItaly

      Regulatory compliance

      EDQM
      KDMF
      GDUFA
      FDA
      CEP COS
      USDMF
      NDC API

      Audit standards

      GMP (APIs)

      Company description

      With almost a century of experience behind it, Bioindustria LIM is today a point of reference at a national and international level, both for the specialization of its production and for the modernity of its research laboratories and its industrial plants.

    • Small logo of Piramal Pharma Solutions

      Piramal Pharma Solutions

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of United States of AmericaUnited States of America

      Sites

      Flag of IndiaIndia
      Flag of United KingdomUnited Kingdom
      Flag of United States of AmericaUnited States of America
      Flag of NetherlandsNetherlands
      Flag of CanadaCanada

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      Piramal Group has interests in a portfolio of businesses including financial services (Piramal Enterprises Limited), pharmaceuticals (Piramal Pharma Limited), and real estate (Piramal Realty). With operations in 30 countries and brand presence in over 100 markets, the Group’s turnover is ~$1.9 billion in FY 2022. Driven by its core values, the Group pursues inclusive growth, while adhering to ethical and value-driven practices. Piramal Foundation has initiatives in primary healthcare, nutrition, water, and social sector ecosystems.

    • Small logo of Qilu Pharmaceutical

      Qilu 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
      KDMF
      JDMF
      FDA
      GDUFA
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (APIs)

      Company description

      Established in 1958, Qilu Pharmaceutical is now one of the leading vertically integrated pharmaceutical companies in China that develops, manufactures and distributes both Finished Dosage Forms (FDFs) and Active Pharmaceutical Ingredients (APIs). Qilu currently has 12 subsidiaries, 11 domestic manufacturing sites and over 3,9000 employees worldwide. Qilu ranks among Top 5 in Chinese pharmaceutical industry in 2022. Dedicated to offering high-quality & trustworthy medicines to the world and improving people‘s well-being, Qilu is vigorously exporting its products to over 100 countries and regions around the world.

    • 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 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.

    • 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 Pharmathen

      Pharmathen

      Manufacturer
      Audited

      Headquarters

      Flag of GreeceGreece

      Sites

      Flag of GreeceGreece

      Regulatory compliance

      EDQM
      FDA
      GDUFA
      GDP
      USDMF

      Audit standards

      GMP (Finished Dosage)

      Company description

      Pharmathen aims to provide Life Cycle Management solutions for branded pharma, as well as to develop and establish new technology platforms and provide optimized pharmaceutical products to patients.

    • 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 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 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 Siegfried

      Siegfried

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of SwitzerlandSwitzerland

      Sites

      Flag of ArgentinaArgentina
      Flag of GermanyGermany
      Flag of FranceFrance
      Flag of United States of AmericaUnited States of America
      Flag of SwitzerlandSwitzerland
      Flag of MaltaMalta
      Flag of People's Republic of ChinaPeople's Republic of China

      Regulatory compliance

      GMP
      JDMF
      KDMF
      EDQM
      FDA
      GDUFA
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (Finished Dosage)
      GMP (APIs)

      Company description

      Siegfried serves as your favored associate for comprehensive integrated pharmaceutical ingredient and drug product services with manufacturing capabilities globally. Our expertise is crucial for your venture throughout the entire lifespan. Our enthusiasm lies in creating and producing formulations. It is extraordinary for a provider of development and manufacturing services to possess such a blend of inherent technical expertise and knowledge. Pharmaceutical ingredient services entail Tailored Development and Outsourced Manufacturing for both active pharmaceutical ingredients (API) and intermediates, along with our own range of API (opiates and other regulated substances) and documentation featuring independent patented technologies. Clients utilizing our drug product services benefit from a wealth of inherited expertise in intricate oral drug delivery systems, including sterile filling, backed by in-house development, customer development and manufacturing, and a wide array of completed dosage form products. Enhancing chemical processes and formulations is our area of specialization. We collaborate closely with clients to innovate and enhance chemical processes, thus providing additional benefits and value. Siegfried operates at 11 locations globally, spanning both the Eastern and Western Hemispheres, with multi-purpose cGMP chemical manufacturing facilities in Zofingen, Switzerland; Pennsville, New Jersey, USA; Nantong, China; Minden, Germany; Saint-Vulbas, France; Evionnaz, Switzerland; and sites for manufacturing drug products in Zofingen, Switzerland; Malta; Hameln, Germany, Irvine, USA; Barberà del Vallès, Spain and El Masnou, Spain. Count on Siegfried as your preferred partner for more opportunities.

    • Small logo of Merck & Co

      Merck & Co

      Manufacturer

      Headquarters

      Flag of United States of AmericaUnited States of America

      Sites

      Flag of IndiaIndia
      Flag of IrelandIreland
      Flag of Puerto RicoPuerto Rico
      Flag of People's Republic of ChinaPeople's Republic of China
      Flag of United States of AmericaUnited States of America
      Flag of United KingdomUnited Kingdom
      Flag of NetherlandsNetherlands
      Flag of SingaporeSingapore

      Regulatory compliance

      EU WC
      KDMF
      JDMF
      FDA
      EDQM
      USDMF
      NDC API
      CEP COS

      Company description

      Our objective is to pave the path to a more wholesome future. However, we are also concerned about the manner in which we collectively achieve this goal. Being a company whose products impact the well-being of individuals worldwide, we uphold ourselves to a stringent standard and anticipate others to treat us likewise. We are advocates of transparent, truthful, and principled operation with the utmost level of ethics and honesty. This encompasses ensuring the company's compliance with all relevant laws and regulations on a global scale.

    • Small logo of Solara Active Pharma Sciences

      Solara Active Pharma Sciences

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      Solara is an API manufacturer focused on research and customer satisfaction, operating in over 75 countries. They specialize in producing APIs for niche therapeutic categories, including complex products like polymer-based APIs and injectable APIs. The company has a team of experienced scientists supported by 6 manufacturing facilities and 2 R&D centers. Additionally, Solara offers Contract Research and Manufacturing Services (CRAMS) from discovery to late phase commercial manufacturing. Solara Active Pharma Sciences, with roots in Strides Shasun Ltd. and Sequent Scientific Ltd., is committed to providing value-based products while prioritizing customer needs. The company has 140+ scientists working at 2 R&D centers and 4 API manufacturing facilities, all with global approvals and 2 dedicated R&D facilities.

    • 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 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 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 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

    • Guangzhou Tosun Pharmaceutical

      Headquarters

      Flag of People's Republic of ChinaPeople's Republic of China

      Company description

      Established in 1999, Guangzhou Tosun Pharmaceutical specializes in the import and export of Active Pharmaceutical Ingredients, Chemical Raw Materials, Intermediates, Excipients, and Herbal Extracts. The company has evolved into a pharmaceutical group enterprise with comprehensive operations in medicine, related products, processing, manufacturing, and international trade, leveraging its substantial economic resources.

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