US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Grazoprevir API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Grazoprevir manufacturer or Grazoprevir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Grazoprevir manufacturer or Grazoprevir supplier.
PharmaCompass also assists you with knowing the Grazoprevir API Price utilized in the formulation of products. Grazoprevir API Price is not always fixed or binding as the Grazoprevir Price is obtained through a variety of data sources. The Grazoprevir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Grazoprevir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Grazoprevir, including repackagers and relabelers. The FDA regulates Grazoprevir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Grazoprevir 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 Grazoprevir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Grazoprevir supplier is an individual or a company that provides Grazoprevir active pharmaceutical ingredient (API) or Grazoprevir finished formulations upon request. The Grazoprevir suppliers may include Grazoprevir API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Grazoprevir 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 Grazoprevir Drug Master File in Korea (Grazoprevir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Grazoprevir. The MFDS reviews the Grazoprevir KDMF as part of the drug registration process and uses the information provided in the Grazoprevir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Grazoprevir 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 Grazoprevir API can apply through the Korea Drug Master File (KDMF).
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National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Grazoprevir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Grazoprevir API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Grazoprevir as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Grazoprevir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Grazoprevir NDC to their finished compounded human drug products, they may choose to do so.
CLICK HERE to find a list of Grazoprevir suppliers with NDC on PharmaCompass.
Grazoprevir 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 Grazoprevir 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 Grazoprevir GMP manufacturer or Grazoprevir GMP API supplier for your needs.
A Grazoprevir CoA (Certificate of Analysis) is a formal document that attests to Grazoprevir's compliance with Grazoprevir specifications and serves as a tool for batch-level quality control.
Grazoprevir CoA mostly includes findings from lab analyses of a specific batch. For each Grazoprevir 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.
Grazoprevir may be tested according to a variety of international standards, such as European Pharmacopoeia (Grazoprevir EP), Grazoprevir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Grazoprevir USP).