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A Pretomanid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pretomanid, including repackagers and relabelers. The FDA regulates Pretomanid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pretomanid 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 Pretomanid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pretomanid supplier is an individual or a company that provides Pretomanid active pharmaceutical ingredient (API) or Pretomanid finished formulations upon request. The Pretomanid suppliers may include Pretomanid API manufacturers, exporters, distributors and traders.
click here to find a list of Pretomanid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pretomanid DMF (Drug Master File) is a document detailing the whole manufacturing process of Pretomanid active pharmaceutical ingredient (API) in detail. Different forms of Pretomanid DMFs exist exist since differing nations have different regulations, such as Pretomanid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pretomanid DMF submitted to regulatory agencies in the US is known as a USDMF. Pretomanid USDMF includes data on Pretomanid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pretomanid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pretomanid suppliers with USDMF on PharmaCompass.
A Pretomanid written confirmation (Pretomanid WC) is an official document issued by a regulatory agency to a Pretomanid manufacturer, verifying that the manufacturing facility of a Pretomanid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pretomanid APIs or Pretomanid finished pharmaceutical products to another nation, regulatory agencies frequently require a Pretomanid WC (written confirmation) as part of the regulatory process.
click here to find a list of Pretomanid suppliers with Written Confirmation (WC) on PharmaCompass.
Pretomanid 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 Pretomanid 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 Pretomanid GMP manufacturer or Pretomanid GMP API supplier for your needs.
A Pretomanid CoA (Certificate of Analysis) is a formal document that attests to Pretomanid's compliance with Pretomanid specifications and serves as a tool for batch-level quality control.
Pretomanid CoA mostly includes findings from lab analyses of a specific batch. For each Pretomanid 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.
Pretomanid may be tested according to a variety of international standards, such as European Pharmacopoeia (Pretomanid EP), Pretomanid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pretomanid USP).
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