Request a new auditAudit library
Terms & Conditions-Imprint-Data Privacy-Cookie Policy
  1. Supplier directory
  2. Pharmaceutical manufacturers
  3. Montelukast

Pharmaceutical manufacturers of Montelukast

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

​

44results for pharmaceutical manufacturers of Montelukast

Audits


Qualifyze Compliance Rating


Audit standards

Show More

Regulatory compliance

Show More

​

Regulatory Notices


Type


​
Filters:
  • Small logo of Teva Pharmaceutical Industries

    Teva Pharmaceutical Industries

    Manufacturer
    Audited
    Audit report available

    Headquarters

    Flag of IsraelIsrael

    Sites

    Flag of IndiaIndia
    Flag of SpainSpain
    Flag of NetherlandsNetherlands
    Flag of PolandPoland
    Flag of Czech RepublicCzech Republic
    Flag of IsraelIsrael
    Flag of HungaryHungary
    Flag of ItalyItaly
    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
    Flag of CanadaCanada

    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
    Flag of BelgiumBelgium
    Flag of CanadaCanada
    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 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 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
  • 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 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.

Suppliers listed herein are for informational purposes only. Qualifyze does not endorse or recommend any supplier and disclaims any responsibility or liability for any transactions or issues arising from dealings with the listed suppliers.
The use of any automated systems, software, bots, or other known or unknown methods to scrape, extract, or collect data from the Qualifyze's platform, databases, website, or systems for themselves or any commercial purposes is strictly prohibited without Qualifyze's prior written consent.
Some information included may be sourced from the European Medicines Agency website (https://www.ema.europa.eu/) or the U.S. Food & Drug administration website (https://www.fda.gov/). Please note that Qualifyze does not guarantee the completeness or timeliness of the content. Qualifyze is not liable for any inaccuracies, errors or omissions in the content sourced from such sources.

Top searched categories

  • Pharmaceutical distributors
  • Pharmaceutical list of suppliers in India
  • Pharmaceutical list of suppliers in UK
  • Pharmaceutical list of suppliers in USA
  • Pharmaceutical manufacturers

Similar categories to pharmaceutical manufacturers of Montelukast

  1. Monobenzone
  1. Niacin
  1. Mycophenolate mofetil
  1. Sodium alginate
  1. Pantoprazole
  1. Glimepiride
  1. Citalopram
  1. Erythromycin
  1. Ondansetron
  1. Metoprolol succinate
  1. Metoprolol
  1. Mebendazole
  1. Dextroamphetamine
  1. Levothyroxine sodium
  1. Tetracycline
  2. USA