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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - EQ 10MG BASE
USFDA APPLICATION NUMBER - 20829
DOSAGE - TABLET, CHEWABLE;ORAL - EQ 4MG BASE
USFDA APPLICATION NUMBER - 20830
DOSAGE - TABLET, CHEWABLE;ORAL - EQ 5MG BASE
USFDA APPLICATION NUMBER - 20830
DOSAGE - GRANULE;ORAL - EQ 4MG BASE/PACKET
USFDA APPLICATION NUMBER - 21409
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REF. STANDARDS & IMPURITIES
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ANALYTICAL
ABOUT THIS PAGE
77
PharmaCompass offers a list of Montelukast Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
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, and COA related information on PhamaCompass.
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, and COA related information on PharmaCompass.
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.
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.
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.
A Montelukast Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Montelukast Sodium Certificate of Suitability (COS). The purpose of a Montelukast Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Montelukast Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Montelukast Sodium to their clients by showing that a Montelukast Sodium CEP has been issued for it. The manufacturer submits a Montelukast Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Montelukast Sodium CEP holder for the record. Additionally, the data presented in the Montelukast Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Montelukast Sodium DMF.
A Montelukast Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Montelukast Sodium CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Montelukast Sodium suppliers with CEP (COS) on PharmaCompass.
A Montelukast Sodium written confirmation (Montelukast Sodium WC) is an official document issued by a regulatory agency to a Montelukast Sodium manufacturer, verifying that the manufacturing facility of a Montelukast Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Montelukast Sodium APIs or Montelukast Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Montelukast Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Montelukast Sodium suppliers with Written Confirmation (WC) on PharmaCompass.
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 Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Montelukast Sodium API and other APIs are published in this directory by the FDA.
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 Sodium 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.
The NDC directory also contains data on finished compounded human drug products that contain Montelukast Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Montelukast Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Montelukast Sodium suppliers with NDC on PharmaCompass.
Montelukast Sodium Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Montelukast Sodium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Montelukast Sodium GMP manufacturer or Montelukast Sodium GMP API supplier for your needs.
A Montelukast Sodium CoA (Certificate of Analysis) is a formal document that attests to Montelukast Sodium's compliance with Montelukast Sodium specifications and serves as a tool for batch-level quality control.
Montelukast Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Montelukast Sodium CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Montelukast Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Montelukast Sodium EP), Montelukast Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Montelukast Sodium USP).
