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A Drotaverine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Drotaverine, including repackagers and relabelers. The FDA regulates Drotaverine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Drotaverine 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 Drotaverine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Drotaverine supplier is an individual or a company that provides Drotaverine active pharmaceutical ingredient (API) or Drotaverine finished formulations upon request. The Drotaverine suppliers may include Drotaverine API manufacturers, exporters, distributors and traders.
click here to find a list of Drotaverine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Drotaverine written confirmation (Drotaverine WC) is an official document issued by a regulatory agency to a Drotaverine manufacturer, verifying that the manufacturing facility of a Drotaverine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Drotaverine APIs or Drotaverine finished pharmaceutical products to another nation, regulatory agencies frequently require a Drotaverine WC (written confirmation) as part of the regulatory process.
click here to find a list of Drotaverine suppliers with Written Confirmation (WC) on PharmaCompass.
Drotaverine 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 Drotaverine 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 Drotaverine GMP manufacturer or Drotaverine GMP API supplier for your needs.
A Drotaverine CoA (Certificate of Analysis) is a formal document that attests to Drotaverine's compliance with Drotaverine specifications and serves as a tool for batch-level quality control.
Drotaverine CoA mostly includes findings from lab analyses of a specific batch. For each Drotaverine 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.
Drotaverine may be tested according to a variety of international standards, such as European Pharmacopoeia (Drotaverine EP), Drotaverine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Drotaverine USP).
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