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