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API SUPPLIERS
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
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USDMF
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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
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ABOUT THIS PAGE
A Cabotegravir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cabotegravir, including repackagers and relabelers. The FDA regulates Cabotegravir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cabotegravir 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 Cabotegravir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cabotegravir supplier is an individual or a company that provides Cabotegravir active pharmaceutical ingredient (API) or Cabotegravir finished formulations upon request. The Cabotegravir suppliers may include Cabotegravir API manufacturers, exporters, distributors and traders.
click here to find a list of Cabotegravir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cabotegravir DMF (Drug Master File) is a document detailing the whole manufacturing process of Cabotegravir active pharmaceutical ingredient (API) in detail. Different forms of Cabotegravir DMFs exist exist since differing nations have different regulations, such as Cabotegravir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cabotegravir DMF submitted to regulatory agencies in the US is known as a USDMF. Cabotegravir USDMF includes data on Cabotegravir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cabotegravir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cabotegravir 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 Cabotegravir Drug Master File in Korea (Cabotegravir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cabotegravir. The MFDS reviews the Cabotegravir KDMF as part of the drug registration process and uses the information provided in the Cabotegravir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cabotegravir 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 Cabotegravir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cabotegravir 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 Cabotegravir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cabotegravir 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 Cabotegravir 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 Cabotegravir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cabotegravir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cabotegravir suppliers with NDC on PharmaCompass.
Cabotegravir 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 Cabotegravir 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 Cabotegravir GMP manufacturer or Cabotegravir GMP API supplier for your needs.
A Cabotegravir CoA (Certificate of Analysis) is a formal document that attests to Cabotegravir's compliance with Cabotegravir specifications and serves as a tool for batch-level quality control.
Cabotegravir CoA mostly includes findings from lab analyses of a specific batch. For each Cabotegravir 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.
Cabotegravir may be tested according to a variety of international standards, such as European Pharmacopoeia (Cabotegravir EP), Cabotegravir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cabotegravir USP).
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