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Jai Radhe Sales Montelukast sodium Jai Radhe Sales Montelukast sodium

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List of Drug Master Files (DMF) of Montelukast Sodium Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Dr. Reddy's Laboratories (1)

02 Minakem (formerly Delmar Chemicals) (1)

03 Apotex Pharmachem (1)

04 Aurobindo Pharma Limited (1)

05 China Gateway Pharmaceutical Co Ltd (1)

06 Cipla (1)

07 Formosa Laboratories (1)

08 Hetero Drugs (1)

09 LG Life Sciences (1)

10 Laurus Labs (1)

11 Linhai Huanan Chemicals Co., Ltd. (1)

12 Lunan Pharmaceutical (1)

13 MSN Laboratories (3)

14 Macleods Pharmaceuticals Limited (1)

15 Melody Healthcare Pvt Ltd (1)

16 Morepen Laboratories (1)

17 SINTENOVO, S.A. DE C.V. (1)

18 Sun Pharmaceutical Industries Limited (1)

19 Teva API (2)

20 Torrent Pharmaceuticals Limited (1)

21 Unichem Laboratories Limited (1)

22 Unimark Remedies Limited (5)

23 Viatris (1)

24 Zenfold Sustainable Technologies (1)

25 Zhejiang Tianyu Pharmaceutical Co., Ltd (2)

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01 MONTELUKAST BACKONE DIOL (2)

02 MONTELUKAST SODIUM (13)

03 MONTELUKAST SODIUM (NI) (1)

04 MONTELUKAST SODIUM (PROCESS A) (1)

05 MONTELUKAST SODIUM (PROCESS B) (1)

06 MONTELUKAST SODIUM THIOL ACID (1)

07 MONTELUKAST SODIUM USP (8)

08 MONTELUKAST SODIUM USP (NON-STERILE DRUG SUBSTANCE) (1)

09 MONTELUKAST SODIUM USP (PROCESS-C) (1)

10 MONTELUKAST SODIUM USP [ROUTE CODE - "MB"] (1)

11 MONTELUKAST SODIUM USP [ROUTE CODE - "MK"] (1)

12 MONTELUKAST SODIUM USP [ROUTE CODE - MT"] (1)

13 MONTELUKAST SODIUM [PROCESS-2] (1)

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01 Canada (2)

02 China (5)

03 India (20)

04 Israel (2)

05 Mexico (1)

06 South Korea (1)

07 Taiwan (1)

08 U.S.A (1)

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01 Active (24)

02 Inactive (9)

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01 Complete (14)

02 Blank (19)

16243
Active
2002-11-15
N/A
II
Minakem Delmar

Chinaplas 2024

Not Confirmed

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URL Supplier Web Content
23495
Active
2010-01-29
N/A
II
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URL Supplier Web Content
21702
Active
2008-06-16
Complete
2013-07-22
2012-12-03
II
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23736
Active
2010-04-16
Complete
2017-03-24
2017-03-13
II
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20580
Active
2007-06-07
Complete
2015-05-04
2015-04-29
II
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22484
Active
2009-02-05
Complete
2014-01-22
2013-11-12
II
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URL Supplier Web Content
19829
Active
2006-10-04
N/A
II
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24324
Active
2010-11-02
N/A
II
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20425
Active
2007-03-26
Complete
2013-07-11
2013-06-26
II
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Looking for 151767-02-1 / Montelukast Sodium API manufacturers, exporters & distributors?

Montelukast Sodium manufacturers, exporters & distributors 1

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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 USDMF

A Montelukast Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Montelukast Sodium active pharmaceutical ingredient (API) in detail. Different forms of Montelukast Sodium DMFs exist exist since differing nations have different regulations, such as Montelukast Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Montelukast Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Montelukast Sodium USDMF includes data on Montelukast Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Montelukast Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.

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