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ABOUT THIS PAGE
A Rilpivirine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rilpivirine, including repackagers and relabelers. The FDA regulates Rilpivirine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rilpivirine 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 Rilpivirine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rilpivirine supplier is an individual or a company that provides Rilpivirine active pharmaceutical ingredient (API) or Rilpivirine finished formulations upon request. The Rilpivirine suppliers may include Rilpivirine API manufacturers, exporters, distributors and traders.
click here to find a list of Rilpivirine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rilpivirine DMF (Drug Master File) is a document detailing the whole manufacturing process of Rilpivirine active pharmaceutical ingredient (API) in detail. Different forms of Rilpivirine DMFs exist exist since differing nations have different regulations, such as Rilpivirine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rilpivirine DMF submitted to regulatory agencies in the US is known as a USDMF. Rilpivirine USDMF includes data on Rilpivirine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rilpivirine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rilpivirine 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 Rilpivirine Drug Master File in Korea (Rilpivirine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rilpivirine. The MFDS reviews the Rilpivirine KDMF as part of the drug registration process and uses the information provided in the Rilpivirine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rilpivirine 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 Rilpivirine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rilpivirine suppliers with KDMF on PharmaCompass.
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 Rilpivirine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rilpivirine 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 Rilpivirine 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 Rilpivirine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rilpivirine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rilpivirine suppliers with NDC on PharmaCompass.
Rilpivirine 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 Rilpivirine 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 Rilpivirine GMP manufacturer or Rilpivirine GMP API supplier for your needs.
A Rilpivirine CoA (Certificate of Analysis) is a formal document that attests to Rilpivirine's compliance with Rilpivirine specifications and serves as a tool for batch-level quality control.
Rilpivirine CoA mostly includes findings from lab analyses of a specific batch. For each Rilpivirine 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.
Rilpivirine may be tested according to a variety of international standards, such as European Pharmacopoeia (Rilpivirine EP), Rilpivirine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rilpivirine USP).
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