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USDMF
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DOSAGE - TABLET;ORAL - EQ 30MG BASE;120MG;EQ ...DOSAGE - TABLET;ORAL - EQ 30MG BASE;120MG;EQ 15MG BASE
USFDA APPLICATION NUMBER - 210251
DOSAGE - TABLET;ORAL - EQ 50MG BASE;200MG;EQ ...DOSAGE - TABLET;ORAL - EQ 50MG BASE;200MG;EQ 25MG BASE
USFDA APPLICATION NUMBER - 210251
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ABOUT THIS PAGE
A Bictegravir Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bictegravir Sodium, including repackagers and relabelers. The FDA regulates Bictegravir Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bictegravir 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 Bictegravir Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bictegravir Sodium supplier is an individual or a company that provides Bictegravir Sodium active pharmaceutical ingredient (API) or Bictegravir Sodium finished formulations upon request. The Bictegravir Sodium suppliers may include Bictegravir Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Bictegravir Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bictegravir Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Bictegravir Sodium active pharmaceutical ingredient (API) in detail. Different forms of Bictegravir Sodium DMFs exist exist since differing nations have different regulations, such as Bictegravir Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bictegravir Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Bictegravir Sodium USDMF includes data on Bictegravir Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bictegravir Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bictegravir 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 Bictegravir Sodium Drug Master File in Korea (Bictegravir Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bictegravir Sodium. The MFDS reviews the Bictegravir Sodium KDMF as part of the drug registration process and uses the information provided in the Bictegravir Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bictegravir 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 Bictegravir Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bictegravir Sodium suppliers with KDMF on PharmaCompass.
A Bictegravir Sodium written confirmation (Bictegravir Sodium WC) is an official document issued by a regulatory agency to a Bictegravir Sodium manufacturer, verifying that the manufacturing facility of a Bictegravir Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bictegravir Sodium APIs or Bictegravir Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Bictegravir Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Bictegravir Sodium suppliers with Written Confirmation (WC) 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 Bictegravir Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bictegravir 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 Bictegravir 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 Bictegravir Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bictegravir Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bictegravir Sodium suppliers with NDC on PharmaCompass.
Bictegravir 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 Bictegravir 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 Bictegravir Sodium GMP manufacturer or Bictegravir Sodium GMP API supplier for your needs.
A Bictegravir Sodium CoA (Certificate of Analysis) is a formal document that attests to Bictegravir Sodium's compliance with Bictegravir Sodium specifications and serves as a tool for batch-level quality control.
Bictegravir Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Bictegravir 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.
Bictegravir Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Bictegravir Sodium EP), Bictegravir Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bictegravir Sodium USP).
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