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01 1Metrochem API Private Limited (Unit-I)

02 1Dr. Reddy's Laboratories Ltd.

03 2Teva API India Private Limited Gajraula site

04 1Enaltec Labs Private Limited

05 1Hanmi Precision Chemical Co., Ltd.

06 1Hetero Drugs Limited(Unit-I)

07 1Hwail Pharmaceutical Co., Ltd.

08 1Kyungbo Pharmaceutical Co., Ltd.

09 2Laurus Labs Limited

10 1MSD International GmbH T/A MSD Ireland (Ballydine)

11 3MSN Pharmachem Private Limited

12 2Macleods Pharmaceuticals Limited

13 2Melody Healthcare Pvt. Ltd

14 3Morepen Laboratories Limited

15 1Tianish Laboratories Limited (Unit-1)

16 1Zhejiang Tianyu Pharmaceutical Co., Ltd.

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PharmaCompass

01

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

Montelukast sodium

Registrant Name : Toru Corporation

Registration Date : 2021-05-04

Registration Number : 20210504-209-J-753

Manufacturer Name : Metrochem API Private Limite...

Manufacturer Address : Plot No. 62/C/6, Pipeline Road, Phase - I, IDA., Jeedimetla, Quthbullapur Mandal Medc...

Metrochem

02

  • fda
  • EDQM
  • WHO-GMP

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

Montelukast sodium

Registrant Name : Pami Future Co., Ltd.

Registration Date : 2022-06-29

Registration Number : 20220629-209-J-1272

Manufacturer Name : Dr. Reddy's Laboratories Ltd...

Manufacturer Address : Chemical Technical Operations-Unit-Ⅴ, Peddadevulapally Village, Tripuraram Mandal, ...

Dr Reddy Company Banner

03

  • 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

Registrant Name : Korea Pharmaceutical Co., Ltd.

Registration Date : 2019-03-06

Registration Number : 20180208-209-J-62(1)

Manufacturer Name : Teva API India Private Limit...

Manufacturer Address : Plot No. A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Bijnor Road, Gajraula-244 235, Di...

TAPI Company Banner

04

  • 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

Registrant Name : Samoh Pharmaceutical Co., Ltd.

Registration Date : 2018-02-08

Registration Number : 20180208-209-J-62

Manufacturer Name : Teva API India Private Limit...

Manufacturer Address : Plot No. A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Bijnor Road, Gajraula -244 235,Di...

TAPI Company Banner

05

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Montelukast sodium

Registrant Name : Samoh Pharmaceutical Co., Ltd.

Registration Date : 2023-01-16

Registration Number : 20230116-209-J-1429

Manufacturer Name : Enaltec Labs Private Limited

Manufacturer Address : Plot no. 825, 826, 827, Industrial Area, Sector-3, Pithampur, Distt-Dhar, MP, India

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06

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Montelukast sodium

Registrant Name : Hanyoung Farm Co., Ltd.

Registration Date : 2022-07-06

Registration Number : 20190426-209-J-170(1)

Manufacturer Name : Laurus Labs Limited

Manufacturer Address : Plot No.21, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam-531021, Andhra Prad...

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07

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Montelukast sodium

Registrant Name : Cosmax Pharma Co., Ltd.

Registration Date : 2023-11-07

Registration Number : 20200814-209-J-717(1)

Manufacturer Name : Macleods Pharmaceuticals Lim...

Manufacturer Address : Plot No. 2209, GIDC Industrial Estate., At & Post : Sarigam, Tal- Umbergaon, City : S...

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08

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Montelukast sodium

Registrant Name : Hyundai Bioland Co., Ltd.

Registration Date : 2023-03-03

Registration Number : 20190226-209-J-182(2)

Manufacturer Name : Morepen Laboratories Limited

Manufacturer Address : Village-Masulkhana, Parwanoo, Distt. Solan (Himachal Pradesh), India

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09

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Montelukast sodium

Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

Registration Date : 2024-06-28

Registration Number : 20200221-209-J-431(A)

Manufacturer Name : MSN Pharmachem Private Limit...

Manufacturer Address : Plot. No. 182 to 186 ,192-A, 193 to 197 & 212/A,B,C,D,Phase-II, IDA Pashamylaram, Pas...

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10

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Montelukast sodium

Registrant Name : Korea United Pharmaceutical Co., Ltd.

Registration Date : 2024-05-01

Registration Number : 20200221-209-J-431(1)

Manufacturer Name : MSN Pharmachem Private Limit...

Manufacturer Address : Plot No. 212/A, B, C, D, Phase-II, IDA Pashamylaram, Pashamylaram(Village), Patancher...

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Montelukast Sodium Manufacturers

A Montelukast Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Montelukast Sodium, including repackagers and relabelers. The FDA regulates Montelukast Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Montelukast Sodium 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 Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Montelukast Sodium Suppliers

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

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

Montelukast Sodium KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Montelukast Sodium Drug Master File in Korea (Montelukast Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Montelukast Sodium. The MFDS reviews the Montelukast Sodium KDMF as part of the drug registration process and uses the information provided in the Montelukast Sodium KDMF to evaluate the safety and efficacy of the drug.

After submitting a Montelukast Sodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Montelukast Sodium API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Montelukast Sodium suppliers with KDMF 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.