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Jai Radhe Sales Montelukast sodium Jai Radhe Sales Montelukast sodium

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List of Drug Master Files (KDMF) for Montelukast Sodium Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Metrochem API Private Limited (Unit-I) (1)

02 Dr. Reddy's Laboratories Ltd. (1)

03 Enaltec Labs Private Limited (1)

04 Hanmi Fine Chemical Co., Ltd. (1)

05 Hetero Drugs Limited (Unit-I) (1)

06 Hwail Pharmaceutical Co., Ltd. (1)

07 Kyeong Pharmaceutical Co., Ltd. (1)

08 Laurus Labs Limited (2)

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

10 MSN Pharmachem Private Limited (1)

11 Macleods Pharmaceuticals Limited (2)

12 Melody Healthcare Pvt. Ltd (2)

13 Morepen Laboratories Limited (3)

14 Mylan Laboratories Limited (Unit-1) (1)

15 Teva API India Private Limited Gajraula site (2)

16 Zhejiang Tianyu Pharmaceutical Co., Ltd. (1)

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01 Ace Biopharm Co., Ltd. (1)

02 Aging Life Science Co., Ltd. (1)

03 Boryeong Co., Ltd. (1)

04 Chemipharm Co., Ltd. (1)

05 Classia Co., Ltd. (1)

06 Cosmax Pharma Co., Ltd. (1)

07 Farmirae Co., Ltd. (1)

08 Hanmi Fine Chemical Co., Ltd. (1)

09 Hanyoung Farm Co., Ltd. (2)

10 Hwail Pharmaceutical Co., Ltd. (1)

11 Hyundai Bioland Co., Ltd. (1)

12 Korea Organon Co., Ltd. (1)

13 Korea Pharmaceutical Co., Ltd. (1)

14 Kyungbo Pharmaceutical Co., Ltd. (1)

15 Leesung International Co., Ltd. (1)

16 Otran Farm Korea Co., Ltd. (1)

17 Pharmapia Co., Ltd. (1)

18 Samo Pharmaceutical Co., Ltd. (2)

19 Sungjin Exim Co., Ltd. (1)

20 Toru Co., Ltd. (1)

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01 montelukast sodium (22)

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01 China (1)

02 India (14)

03 Israel (2)

04 South Korea (3)

05 U.S.A (2)

Toru Co., Ltd.
2021-05-04
20210504-209-J-753
Metrochem API Private Lim...
India
Plot No. 62/C/6, Pipeline...
Farmirae Co., Ltd.
2022-06-29
20220629-209-J-1272
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
URL Supplier Web Content
Samo Pharmaceutical Co., Ltd.
2023-01-16
20230116-209-J-1429
Enaltec Labs Private Limi...
India
Plot no. 825, 826, 827, I...
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Hanmi Fine Chemical Co., Ltd.
2022-01-24
20220124-209-J-1224
Hanmi Fine Chemical Co., ...
South Korea
57 Gyeongje-ro, Siheung-s...
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Hwail Pharmaceutical Co., Ltd.
2021-09-28
20210928-209-J-1111
Hwail Pharmaceutical Co.,...
South Korea
57, Jaekongdan 3-gil, Hya...
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Hanyoung Farm Co., Ltd.
2022-07-06
20190426-209-J-170(1)
Laurus Labs Limited
India
Plot No.21, Jawaharlal Ne...
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Cosmax Pharma Co., Ltd.
2023-11-07
20200814-209-J-717(1)
Macleods Pharmaceuticals ...
India
Plot No. 2209, GIDC Indus...
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Hanyoung Farm Co., Ltd.
2022-05-10
20201117-209-J-782(1)
Melody Healthcare Pvt. Lt...
India
Plot No. J-73, MIDC, Tara...
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Hyundai Bioland Co., Ltd.
2023-03-03
20190226-209-J-182(2)
Morepen Laboratories Limi...
India
Village-Masulkhana, Parwa...
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Otran Farm Korea Co., Ltd.
2022-05-12
20220512-209-J-1243
Zhejiang Tianyu Pharmaceu...
China
No.15, Donghai 5th Avenue...
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Looking for 151767-02-1 / Montelukast Sodium API manufacturers, exporters & distributors?

Montelukast Sodium manufacturers, exporters & distributors 1

22

PharmaCompass offers a list of Montelukast Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Montelukast Sodium manufacturer or Montelukast Sodium supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Montelukast Sodium manufacturer or Montelukast Sodium supplier.

PharmaCompass also assists you with knowing the Montelukast Sodium API Price utilized in the formulation of products. Montelukast Sodium API Price is not always fixed or binding as the Montelukast Sodium Price is obtained through a variety of data sources. The Montelukast Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Montelukast Sodium

Synonyms

151767-02-1, Singulair, Montair, Montelukast sodium salt, Montelukast sodium [usan], Montelukast (sodium)

Cas Number

151767-02-1

Unique Ingredient Identifier (UNII)

U1O3J18SFL

About Montelukast Sodium

Montelukast Sodium is the orally bioavailable monosodium salt of montelukast, a selective cysteinyl leukotriene receptor antagonist with anti-inflammatory and bronchodilating activities. Montelukast selectively and competitively blocks the cysteinyl leukotriene 1 (CysLT1) receptor, preventing binding of the inflammatory mediator leukotriene D4 (LTD4). Inhibition of LTD4 activity results in inhibition of leukotriene-mediated inflammatory events including: migration of eosinophils and neutrophils; adhesion of leukocytes to vascular endothelium, monocyte and neutrophil aggregation; increased airway edema; increased capillary permeability; and bronchoconstriction. The CysLT1 receptor is found in a number of tissues including spleen, lung, placenta, small intestine, and nasal mucosa, and in a variety of cell types including monocyte/macrophages, mast cells, eosinophils, CD34-positive hemopoietic progenitor cells, neutrophils and endothelial cells.

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.

Montelukast Sodium Manufacturers | Traders | Suppliers

Montelukast Sodium Manufacturers, Traders, Suppliers 1
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.
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