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    Pharmaceutical manufacturers of Montelukast sodium

    Find trusted suppliers of Montelukast sodium. Explore verified pharmaceutical manufacturers worldwide for your sourcing needs.

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    41results for pharmaceutical manufacturers of Montelukast sodium

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    • Small logo of Teva Pharmaceutical Industries

      Teva Pharmaceutical Industries

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IsraelIsrael

      Sites

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      Flag of CroatiaCroatia
      Flag of MaltaMalta
      Flag of People's Republic of ChinaPeople's Republic of China
      Flag of Puerto RicoPuerto Rico
      Flag of MexicoMexico
      Flag of United States of AmericaUnited States of America
      Flag of GermanyGermany
      Flag of LithuaniaLithuania
      Flag of United KingdomUnited Kingdom
      Flag of IrelandIreland
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      Regulatory compliance

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

      Audit standards

      GMP (Finished Dosage)
      Sterile FDF
      GMP (APIs)

      Company description

      TAPI stands as the primary global provider of active pharmaceutical ingredients (APIs). With the most extensive range of over 370 high-caliber API products in the industry, we cater to almost 1,000 clients across more than 100 nations. Operating as an independent division under Teva Pharmaceutical Industries, our legacy in the generic API sector spans over 80 years. Situated in close proximity to Tel Aviv, Israel, TAPI boasts a workforce of over 5,000 professionals spread across 19 facilities worldwide. Our cutting-edge manufacturing plants are situated in Italy, Hungary, the Czech Republic, Croatia, Israel, India, China, Mexico, and several other locations.

    • Small logo of Unichem Laboratories

      Unichem Laboratories

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of SpainSpain

      Regulatory compliance

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

      Audit standards

      GMP (APIs)
      GMP (Finished Dosage)

      Company description

      Unichem Laboratories was founded in 1944 by Late Mr. Amrut Mody, a pioneer in the Indian pharmaceuticals business. With a rich tradition of unwavering quality and reliability, Unichem brings together a unique blend of modern, value-added research and deep knowledge of the Indian pharmaceuticals industry.ç

    • Small logo of Minakem

      Minakem

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of FranceFrance

      Sites

      Flag of FranceFrance
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      Flag of SwedenSweden
      Flag of GermanyGermany

      Regulatory compliance

      EDQM
      FDA
      JDMF
      KDMF
      GDUFA
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (APIs)
      GMP (Excipients)

      Company description

      Minakem is a fully integrated commercial manufacturer of Active Pharmaceutical Ingredients (APIs) with R&D capabilities to develop and transfer the manufacturing process to one of its four API facilities in Europe or Canada

    • 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 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.

    • 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.

    • Small logo of Macleods Pharmaceuticals

      Macleods Pharmaceuticals

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (Finished Dosage)
      GMP (APIs)
    • Sintenovo

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of MexicoMexico

      Sites

      Flag of MexicoMexico

      Regulatory compliance

      KDMF
      FDA
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (APIs)

      Company description

      Sintenovo, the Mexican branch of Esteve Quimica from Spain, is dedicated to the development, manufacturing, and marketing of advanced intermediates and API’s for various markets including Mexico, the US, and Europe. Sintenovo’s multipurpose plant in Jiutepec adheres to cGMP standards and has a total capacity of 140 m3. It has successfully passed inspections and received approval from the FDA, PMDA, as well as the Mexican and EU authorities.

    • Small logo of Seqens

      Seqens

      Manufacturer

      Headquarters

      Flag of FranceFrance

      Sites

      Flag of FranceFrance
      Flag of FinlandFinland
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      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
    • Enaltec Labs

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (Subcontracted Laboratory)

      Company description

      Enaltec was established in 2006 by a group of young and experienced professionals with the specific objective to develop and produce complex, small volume, technology-driven products at competitive prices, thus providing the critical India advantage to generic formulators across the world.

    • 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 Viatris

      Viatris

      Manufacturer

      Headquarters

      Flag of United States of AmericaUnited States of America

      Sites

      Flag of United States of AmericaUnited States of America
      Flag of CanadaCanada
      Flag of IrelandIreland
      Flag of IndiaIndia
      Flag of PolandPoland
      Flag of Puerto RicoPuerto Rico
      Flag of AustraliaAustralia

      Regulatory compliance

      WHO GMP
      FDA
      GDUFA
      EDQM
      GDP

      Company description

      VIATRIS™ represents a fresh approach to healthcare, dedicated to ensuring medicine accessibility, promoting sustainable practices, pioneering creative remedies, and enhancing patient results. Founded in 2020 through the merger of Mylan and Upjohn, Viatris unites top-notch scientific, production and distribution skills with established regulatory, medical and commercial proficiencies.

    • 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 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 Shilpa Medicare

      Shilpa Medicare

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of PolandPoland

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      We specialize in premium Active Pharmaceutical Ingredients (APIs), Formulations, Innovative Drug Delivery Systems, and Specialty Chemicals using advanced technology with precision to adhere to global standards/specifications. Presently, we are recognized as one of the foremost global providers of Oncology/non-Oncology APIs, intermediates, and Formulations. Shilpa Medicare’s establishments have garnered significant regulatory endorsements from USFDA, EUGMP, TGA, PMDA, Cofepris, Anvisa, and KFDA, encompassing diverse regulatory approved manufacturing standards.

    • 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 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 Aarti Pharmalabs

      Aarti Pharmalabs

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      Aarti Pharmalabs Limited, also known as APL, is a prominent Indian producer of Pharmaceuticals and Nutraceuticals with an international presence. Our product range includes Generic APIs, Intermediates, and Xanthine derivatives such as Caffeine. We specialize in providing CDMO services for small molecule drug substances, focusing on process development and manufacturing for both clinical and commercial phase projects intended for Innovator companies. Additionally, we have specialized facilities dedicated to the manufacturing of HPAPIs, Corticosteroids, and Cytotoxic and Oncology products.

    • Small logo of Torrent Pharmaceuticals

      Torrent Pharmaceuticals

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of IndiaIndia

      Sites

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

      Regulatory compliance

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

      Audit standards

      GMP (Finished Dosage)
      GMP (APIs)
    • 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.

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