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USDMF
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-21
Pay. Date : 2016-08-16
DMF Number : 30287
Submission : 2016-09-07
Status :
Type : II
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Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Cobicistat on colloidal silicon dioxide IH
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0362
Address of the Firm : Plot No:4, Hetero Infrastructure SEZ Ltd.,Narasapuram, Visakhapatnam-531081, And...
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DOSAGE - TABLET;ORAL - 150MG;150MG;200MG;300M...DOSAGE - TABLET;ORAL - 150MG;150MG;200MG;300MG
USFDA APPLICATION NUMBER - 203100
DOSAGE - TABLET;ORAL - EQ 300MG BASE;150MG
USFDA APPLICATION NUMBER - 206353
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
49
PharmaCompass offers a list of Cobicistat API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Cobicistat manufacturer or Cobicistat supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cobicistat manufacturer or Cobicistat supplier.
PharmaCompass also assists you with knowing the Cobicistat API Price utilized in the formulation of products. Cobicistat API Price is not always fixed or binding as the Cobicistat Price is obtained through a variety of data sources. The Cobicistat Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cobicistat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cobicistat, including repackagers and relabelers. The FDA regulates Cobicistat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cobicistat 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 Cobicistat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cobicistat supplier is an individual or a company that provides Cobicistat active pharmaceutical ingredient (API) or Cobicistat finished formulations upon request. The Cobicistat suppliers may include Cobicistat API manufacturers, exporters, distributors and traders.
click here to find a list of Cobicistat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cobicistat DMF (Drug Master File) is a document detailing the whole manufacturing process of Cobicistat active pharmaceutical ingredient (API) in detail. Different forms of Cobicistat DMFs exist exist since differing nations have different regulations, such as Cobicistat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cobicistat DMF submitted to regulatory agencies in the US is known as a USDMF. Cobicistat USDMF includes data on Cobicistat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cobicistat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cobicistat suppliers with USDMF on PharmaCompass.
A Cobicistat written confirmation (Cobicistat WC) is an official document issued by a regulatory agency to a Cobicistat manufacturer, verifying that the manufacturing facility of a Cobicistat active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cobicistat APIs or Cobicistat finished pharmaceutical products to another nation, regulatory agencies frequently require a Cobicistat WC (written confirmation) as part of the regulatory process.
click here to find a list of Cobicistat 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 Cobicistat as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cobicistat 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 Cobicistat 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 Cobicistat and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cobicistat NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cobicistat suppliers with NDC on PharmaCompass.
Cobicistat 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 Cobicistat 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 Cobicistat GMP manufacturer or Cobicistat GMP API supplier for your needs.
A Cobicistat CoA (Certificate of Analysis) is a formal document that attests to Cobicistat's compliance with Cobicistat specifications and serves as a tool for batch-level quality control.
Cobicistat CoA mostly includes findings from lab analyses of a specific batch. For each Cobicistat 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.
Cobicistat may be tested according to a variety of international standards, such as European Pharmacopoeia (Cobicistat EP), Cobicistat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cobicistat USP).
