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API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Oxiracetam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxiracetam, including repackagers and relabelers. The FDA regulates Oxiracetam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxiracetam 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 Oxiracetam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxiracetam supplier is an individual or a company that provides Oxiracetam active pharmaceutical ingredient (API) or Oxiracetam finished formulations upon request. The Oxiracetam suppliers may include Oxiracetam API manufacturers, exporters, distributors and traders.
click here to find a list of Oxiracetam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxiracetam DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxiracetam active pharmaceutical ingredient (API) in detail. Different forms of Oxiracetam DMFs exist exist since differing nations have different regulations, such as Oxiracetam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxiracetam DMF submitted to regulatory agencies in the US is known as a USDMF. Oxiracetam USDMF includes data on Oxiracetam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxiracetam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxiracetam 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 Oxiracetam Drug Master File in Korea (Oxiracetam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oxiracetam. The MFDS reviews the Oxiracetam KDMF as part of the drug registration process and uses the information provided in the Oxiracetam KDMF to evaluate the safety and efficacy of the drug.
After submitting a Oxiracetam 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 Oxiracetam API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Oxiracetam suppliers with KDMF on PharmaCompass.
Oxiracetam 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 Oxiracetam 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 Oxiracetam GMP manufacturer or Oxiracetam GMP API supplier for your needs.
A Oxiracetam CoA (Certificate of Analysis) is a formal document that attests to Oxiracetam's compliance with Oxiracetam specifications and serves as a tool for batch-level quality control.
Oxiracetam CoA mostly includes findings from lab analyses of a specific batch. For each Oxiracetam 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.
Oxiracetam may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxiracetam EP), Oxiracetam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxiracetam USP).
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