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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
Vital Laboratories – Trusted Global API Manufacturer of Quinine, Hyoscine, Antimalarials & Vitamins
MX
Cerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.
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USDMF
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt. Ltd. is an ISO 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), phytochemicals, herba...
Vital Laboratories – Trusted Global API Manufacturer of Quinine, Hyoscine, Antimalarials & Vitamins
About the Company : Vital Laboratories is an API and intermediates manufacturer established in 1998, beginning with quinine derivatives. Today, it is a global leader in quinine and hyoscine derivative...
Cerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.
About the Company : Cerata Pharmaceuticals LLP is a WHO-GMP certified pharmaceutical API manufacturer based in Gujarat, India. We specialize in the development and manufacturing of high-quality APIs a...
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Mefenamic Acid 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 Mefenamic Acid manufacturer or Mefenamic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mefenamic Acid manufacturer or Mefenamic Acid supplier.
A Mefenamate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mefenamate, including repackagers and relabelers. The FDA regulates Mefenamate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mefenamate 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 Mefenamate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Mefenamate supplier is an individual or a company that provides Mefenamate active pharmaceutical ingredient (API) or Mefenamate finished formulations upon request. The Mefenamate suppliers may include Mefenamate API manufacturers, exporters, distributors and traders.
click here to find a list of Mefenamate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Mefenamate DMF (Drug Master File) is a document detailing the whole manufacturing process of Mefenamate active pharmaceutical ingredient (API) in detail. Different forms of Mefenamate DMFs exist exist since differing nations have different regulations, such as Mefenamate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mefenamate DMF submitted to regulatory agencies in the US is known as a USDMF. Mefenamate USDMF includes data on Mefenamate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mefenamate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mefenamate 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 Mefenamate Drug Master File in Japan (Mefenamate JDMF) empowers Mefenamate 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 Mefenamate JDMF during the approval evaluation for pharmaceutical products. At the time of Mefenamate 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 Mefenamate 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 Mefenamate Drug Master File in Korea (Mefenamate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mefenamate. The MFDS reviews the Mefenamate KDMF as part of the drug registration process and uses the information provided in the Mefenamate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mefenamate 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 Mefenamate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mefenamate suppliers with KDMF on PharmaCompass.
A Mefenamate CEP of the European Pharmacopoeia monograph is often referred to as a Mefenamate Certificate of Suitability (COS). The purpose of a Mefenamate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mefenamate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mefenamate to their clients by showing that a Mefenamate CEP has been issued for it. The manufacturer submits a Mefenamate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mefenamate CEP holder for the record. Additionally, the data presented in the Mefenamate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mefenamate DMF.
A Mefenamate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mefenamate 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 Mefenamate suppliers with CEP (COS) on PharmaCompass.
A Mefenamate written confirmation (Mefenamate WC) is an official document issued by a regulatory agency to a Mefenamate manufacturer, verifying that the manufacturing facility of a Mefenamate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mefenamate APIs or Mefenamate finished pharmaceutical products to another nation, regulatory agencies frequently require a Mefenamate WC (written confirmation) as part of the regulatory process.
click here to find a list of Mefenamate 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 Mefenamate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mefenamate 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 Mefenamate 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 Mefenamate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mefenamate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mefenamate suppliers with NDC on PharmaCompass.
Mefenamate 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 Mefenamate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Mefenamate GMP manufacturer or Mefenamate GMP API supplier for your needs.
A Mefenamate CoA (Certificate of Analysis) is a formal document that attests to Mefenamate's compliance with Mefenamate specifications and serves as a tool for batch-level quality control.
Mefenamate CoA mostly includes findings from lab analyses of a specific batch. For each Mefenamate 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.
Mefenamate may be tested according to a variety of international standards, such as European Pharmacopoeia (Mefenamate EP), Mefenamate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mefenamate USP).
