Jai Radhe Sales Montelukast sodium Jai Radhe Sales Montelukast sodium

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List of Japan Drug Master File (JDMF) for Montelukast Sodium Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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  • TABLET;ORAL - EQ 10MG BASE
  • TABLET, CHEWABLE;ORAL - EQ 4MG BASE
  • TABLET, CHEWABLE;ORAL - EQ 5MG BASE
  • GRANULE;ORAL - EQ 4MG BASE/PACKET

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 JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Montelukast Sodium Drug Master File in Japan (Montelukast Sodium JDMF) empowers Montelukast Sodium API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Montelukast Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Montelukast Sodium JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Montelukast Sodium suppliers with JDMF 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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