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01 2Dr.Reddy's laboratories Limited

02 1Teva API India Private Ltd

03 1AX Pharmaceutical Corp

04 1Aurobindo Pharma Limited

05 1Formosa Laboratories, Inc.

06 1Hetero Drugs Limited

07 1Laurus Labs Limited

08 1MSD International GmbH

09 1MSN Pharmachem Private Limited

10 1MYLAN LABORATORIES LIMITED

11 1Macleods Pharmaceutical Limited

12 2Morepen Laboratories Limited

13 1Professional Compounding Centers of America

14 1Professional Compounding Centers of America dba PCCA

15 1Tianish Laboratories Private Limited

16 1Unichem Laboratories Limited, India

17 1Zenfold Sustainable Technologies Private Limited

18 1Zhejiang Ausun Pharmaceutical Co., Ltd.

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

MONTELUKAST SODIUM

NDC Package Code : 55111-084

Start Marketing Date : 2010-12-31

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

MONTELUKAST SODIUM

NDC Package Code : 15894-0004

Start Marketing Date : 2019-08-19

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (100kg/100kg)

Marketing Category : BULK INGREDIENT

TAPI Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

MONTELUKAST SODIUM

NDC Package Code : 55111-998

Start Marketing Date : 2006-12-14

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Dr Reddy Company Banner

04

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Not Confirmed
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06

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MONTELUKAST SODIUM

NDC Package Code : 50473-0002

Start Marketing Date : 2002-07-26

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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08

Cosmoprof
Not Confirmed
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MONTELUKAST SODIUM

NDC Package Code : 51927-0018

Start Marketing Date : 2014-02-19

End Marketing Date : 2026-06-01

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT FOR HUMAN P...

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09

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MONTELUKAST SODIUM

NDC Package Code : 51927-0347

Start Marketing Date : 2024-08-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (5kg/5kg)

Marketing Category : BULK INGREDIENT FOR HUMAN P...

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10

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Montelukast Manufacturers

A Montelukast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Montelukast, including repackagers and relabelers. The FDA regulates Montelukast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Montelukast API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Montelukast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Montelukast Suppliers

A Montelukast supplier is an individual or a company that provides Montelukast active pharmaceutical ingredient (API) or Montelukast finished formulations upon request. The Montelukast suppliers may include Montelukast API manufacturers, exporters, distributors and traders.

click here to find a list of Montelukast suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Montelukast NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Montelukast as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Montelukast API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Montelukast as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Montelukast and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Montelukast NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Montelukast suppliers with NDC on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.