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USDMF
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USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
(R)-(-)-2-Amino-3-methyl-1-butanol
CAS Number : 4276-09-9
End Use API : Elvitegravir
About The Company : USV is a leading health care company with focus on Active Pharmaceutical Ingredients (marketed globally with emphasis on regulated markets of USA, European Unio...
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DOSAGE - TABLET;ORAL - 150MG
USFDA APPLICATION NUMBER - 203093
DOSAGE - TABLET;ORAL - 85MG
USFDA APPLICATION NUMBER - 203093
DOSAGE - TABLET;ORAL - 150MG;150MG;200MG;300M...DOSAGE - TABLET;ORAL - 150MG;150MG;200MG;300MG
USFDA APPLICATION NUMBER - 203100
DOSAGE - TABLET;ORAL - 150MG;150MG;200MG;EQ 1...DOSAGE - TABLET;ORAL - 150MG;150MG;200MG;EQ 10MG BASE
USFDA APPLICATION NUMBER - 207561
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ABOUT THIS PAGE
A Elvitegravir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elvitegravir, including repackagers and relabelers. The FDA regulates Elvitegravir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elvitegravir 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 Elvitegravir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Elvitegravir supplier is an individual or a company that provides Elvitegravir active pharmaceutical ingredient (API) or Elvitegravir finished formulations upon request. The Elvitegravir suppliers may include Elvitegravir API manufacturers, exporters, distributors and traders.
click here to find a list of Elvitegravir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Elvitegravir DMF (Drug Master File) is a document detailing the whole manufacturing process of Elvitegravir active pharmaceutical ingredient (API) in detail. Different forms of Elvitegravir DMFs exist exist since differing nations have different regulations, such as Elvitegravir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Elvitegravir DMF submitted to regulatory agencies in the US is known as a USDMF. Elvitegravir USDMF includes data on Elvitegravir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Elvitegravir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Elvitegravir 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 Elvitegravir Drug Master File in Korea (Elvitegravir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Elvitegravir. The MFDS reviews the Elvitegravir KDMF as part of the drug registration process and uses the information provided in the Elvitegravir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Elvitegravir 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 Elvitegravir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Elvitegravir suppliers with KDMF on PharmaCompass.
A Elvitegravir written confirmation (Elvitegravir WC) is an official document issued by a regulatory agency to a Elvitegravir manufacturer, verifying that the manufacturing facility of a Elvitegravir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Elvitegravir APIs or Elvitegravir finished pharmaceutical products to another nation, regulatory agencies frequently require a Elvitegravir WC (written confirmation) as part of the regulatory process.
click here to find a list of Elvitegravir 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 Elvitegravir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Elvitegravir 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 Elvitegravir 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 Elvitegravir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Elvitegravir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Elvitegravir suppliers with NDC on PharmaCompass.
Elvitegravir 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 Elvitegravir 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 Elvitegravir GMP manufacturer or Elvitegravir GMP API supplier for your needs.
A Elvitegravir CoA (Certificate of Analysis) is a formal document that attests to Elvitegravir's compliance with Elvitegravir specifications and serves as a tool for batch-level quality control.
Elvitegravir CoA mostly includes findings from lab analyses of a specific batch. For each Elvitegravir 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.
Elvitegravir may be tested according to a variety of international standards, such as European Pharmacopoeia (Elvitegravir EP), Elvitegravir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Elvitegravir USP).
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