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