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