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USDMF
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API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] Listed Suppliers
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Bilberry manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bilberry, including repackagers and relabelers. The FDA regulates Bilberry manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bilberry 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 Bilberry manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bilberry supplier is an individual or a company that provides Bilberry active pharmaceutical ingredient (API) or Bilberry finished formulations upon request. The Bilberry suppliers may include Bilberry API manufacturers, exporters, distributors and traders.
click here to find a list of Bilberry suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Bilberry Drug Master File in Korea (Bilberry KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bilberry. The MFDS reviews the Bilberry KDMF as part of the drug registration process and uses the information provided in the Bilberry KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bilberry 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 Bilberry API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bilberry suppliers with KDMF on PharmaCompass.
A Bilberry CEP of the European Pharmacopoeia monograph is often referred to as a Bilberry Certificate of Suitability (COS). The purpose of a Bilberry CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bilberry EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bilberry to their clients by showing that a Bilberry CEP has been issued for it. The manufacturer submits a Bilberry CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bilberry CEP holder for the record. Additionally, the data presented in the Bilberry CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bilberry DMF.
A Bilberry CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bilberry CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Bilberry suppliers with CEP (COS) on PharmaCompass.
Bilberry 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 Bilberry 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 Bilberry GMP manufacturer or Bilberry GMP API supplier for your needs.
A Bilberry CoA (Certificate of Analysis) is a formal document that attests to Bilberry's compliance with Bilberry specifications and serves as a tool for batch-level quality control.
Bilberry CoA mostly includes findings from lab analyses of a specific batch. For each Bilberry 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.
Bilberry may be tested according to a variety of international standards, such as European Pharmacopoeia (Bilberry EP), Bilberry JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bilberry USP).
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