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CEP/COS
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Certificate Number : CEP 2017-021 - Rev 01
Status : Valid
Issue Date : 2024-03-25
Type : Chemical
Substance Number : 1701
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API Imports and Exports
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ABOUT THIS PAGE
A Molsidomine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Molsidomine, including repackagers and relabelers. The FDA regulates Molsidomine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Molsidomine 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 Molsidomine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Molsidomine supplier is an individual or a company that provides Molsidomine active pharmaceutical ingredient (API) or Molsidomine finished formulations upon request. The Molsidomine suppliers may include Molsidomine API manufacturers, exporters, distributors and traders.
click here to find a list of Molsidomine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Molsidomine Drug Master File in Korea (Molsidomine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Molsidomine. The MFDS reviews the Molsidomine KDMF as part of the drug registration process and uses the information provided in the Molsidomine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Molsidomine 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 Molsidomine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Molsidomine suppliers with KDMF on PharmaCompass.
A Molsidomine CEP of the European Pharmacopoeia monograph is often referred to as a Molsidomine Certificate of Suitability (COS). The purpose of a Molsidomine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Molsidomine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Molsidomine to their clients by showing that a Molsidomine CEP has been issued for it. The manufacturer submits a Molsidomine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Molsidomine CEP holder for the record. Additionally, the data presented in the Molsidomine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Molsidomine DMF.
A Molsidomine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Molsidomine 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 Molsidomine suppliers with CEP (COS) on PharmaCompass.
Molsidomine 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 Molsidomine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Molsidomine GMP manufacturer or Molsidomine GMP API supplier for your needs.
A Molsidomine CoA (Certificate of Analysis) is a formal document that attests to Molsidomine's compliance with Molsidomine specifications and serves as a tool for batch-level quality control.
Molsidomine CoA mostly includes findings from lab analyses of a specific batch. For each Molsidomine 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.
Molsidomine may be tested according to a variety of international standards, such as European Pharmacopoeia (Molsidomine EP), Molsidomine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Molsidomine USP).
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