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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.

    • 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 Lupin

      Lupin

      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 United KingdomUnited Kingdom

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      Headquartered in Mumbai, India, Lupin is a global pharmaceutical leader with a footprint across the U.S., LATAM, APAC, EMEA and India, with products distributed in over 100 markets. With a diverse portfolio of over 1,200 products, Lupin remains committed to its mission of making quality healthcare accessible to the communities we serve. Our visionary Founder, Dr. Desh Bandhu Gupta, instilled in us the importance of offering quality, affordable and innovative medicines and being a responsible corporate citizen, making a positive difference to patients, communities and the environment.

    • Megafine Pharma

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      MEGAFINE provides cutting-edge and comprehensive API solutions and is inspected by regulatory authorities including USFDA, EU-GMP, Australia-TGA, Canada-HC, Korea-MFDS, Japan-PMDA, and Mexico-COFEPRIS. This esteemed manufacturer specializes in high-quality APIs and Intermediates, serving both Innovators and Generic companies. With an impressive track record of 26 US-DMFs, 6 CEPs, and over 250 global regulatory filings, MEGAFINE has recently inaugurated a state-of-the-art API plant to meet its growing demand and expansion.

    • Assia Chemical Industries

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IsraelIsrael

      Sites

      Flag of IsraelIsrael

      Regulatory compliance

      KDMF
      GDUFA
      JDMF
      FDA
      NDC API
      USDMF

      Audit standards

      GMP (APIs)

      Company description

      Teva's roots are deeply rooted in the land of Israel since 1901 in Jerusalem. That's when the first chapter was written in the long and unique history of the company, which slowly transformed from a small drug trading house to the largest generic company in the world, improving the health of millions of patients in Israel and around the world every day.

    • 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 Cadila Pharmaceuticals

      Cadila Pharmaceuticals

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      Cadila Pharmaceuticals Ltd. is one of the largest privately-held pharmaceutical companies in India. Over the past seven decades, we have been developing and manufacturing affordable medicines for patients around the world. Our innovation-led drug discovery processes ensure the health and well-being of people around the world. Our enhanced investment in innovation and a strong track record in research and development have produced medical miracles that have changed lives and made a profound impact on real life.

    • Small logo of Alembic Pharmaceuticals

      Alembic Pharmaceuticals

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      Alembic Pharmaceuticals Limited is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities. Headquartered in Vadodara, Gujarat, we derive a third of our revenue of over $600 million from the India market.

    • 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.

    • 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 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 Moehs Iberica

      Moehs Iberica

      Manufacturer
      Audited

      Headquarters

      Flag of SpainSpain

      Sites

      Flag of SpainSpain

      Regulatory compliance

      EDQM
      KDMF
      JDMF
      USDMF
      CEP COS
      NDC API

      Company description

      Moehs Ibérica is the headquarters of the MOEHS Group. Moehs Ibérica currently has 138 employees in the following departments: Accounting/Treasury, Purchasing/Logistics, Sales/Marketing, Human Resources, IT, Quality Assurance/Regulatory Affairs, Research and Intellectual Property. It provides services to the entire group and each of its subsidiaries. In addition, it has its own R&D building with all its services and a plant dedicated to the production of small quantities of ingredients for the pharmaceutical industry, as well as a plant for the manufacture of High Potency Active Ingredients.

    • 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 Zhejiang Jiuzhou Pharmaceutical

      Zhejiang Jiuzhou 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
      KDMF
      GDUFA
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (APIs)

      Company description

      Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (Abbreviated Name: Jiuzhou Pharma, Stock Code: 603456.SH), founded in 1998 and headquartered in Taizhou, Zhejiang, is a leading contract development and manufacturing organization (CDMO) that successfully evolved from a generic API manufacturer. We provide pharmaceutical companies worldwide with one-stop innovative drug development and manufacturing solutions and services throughout the development lifecycle of an innovative drug—from preclinical chemical manufacturing and control (CMC) through phase I/II/III clinical trials and new drug applications (NDA) to commercialization. As a leader in green pharmaceutical manufacturing, we have developed frontier environmentally-friendly pharmaceutical technologies with independent intellectual property rights. We are committed to providing our customers with industry-leading technical solutions that enhance R&D efficiency and success while reducing costs. Serve life, guard health. We are committed to becoming a distinguished global life science company that provides innovative drug solutions to help our partners accelerate the time to market of innovative drugs and benefit patients worldwide.

    • 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 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 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 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.

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