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API SUPPLIERS
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USDMF
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API Imports and Exports
Drugs in Development
Lead Product(s) : Tazarotene,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Bioavailability Study of DFD-03 Compared to Tazorac® in Patients With Moderate Acne Vulgaris
Details : Tazarotene is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Acne Vulgaris.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 26, 2018
Lead Product(s) : Tazarotene,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks
Details : Tazarotene is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Acne Vulgaris.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 25, 2017
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DOSAGE - AEROSOL, FOAM;TOPICAL - 0.1%
USFDA APPLICATION NUMBER - 202428
DOSAGE - CREAM;TOPICAL - 0.05%
USFDA APPLICATION NUMBER - 21184
DOSAGE - CREAM;TOPICAL - 0.1%
USFDA APPLICATION NUMBER - 21184
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PharmaCompass offers a list of Tazarotene 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 Tazarotene manufacturer or Tazarotene supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tazarotene manufacturer or Tazarotene supplier.
PharmaCompass also assists you with knowing the Tazarotene API Price utilized in the formulation of products. Tazarotene API Price is not always fixed or binding as the Tazarotene Price is obtained through a variety of data sources. The Tazarotene Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tazarotene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tazarotene, including repackagers and relabelers. The FDA regulates Tazarotene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tazarotene 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 Tazarotene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tazarotene supplier is an individual or a company that provides Tazarotene active pharmaceutical ingredient (API) or Tazarotene finished formulations upon request. The Tazarotene suppliers may include Tazarotene API manufacturers, exporters, distributors and traders.
click here to find a list of Tazarotene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tazarotene DMF (Drug Master File) is a document detailing the whole manufacturing process of Tazarotene active pharmaceutical ingredient (API) in detail. Different forms of Tazarotene DMFs exist exist since differing nations have different regulations, such as Tazarotene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tazarotene DMF submitted to regulatory agencies in the US is known as a USDMF. Tazarotene USDMF includes data on Tazarotene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tazarotene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tazarotene suppliers with USDMF on PharmaCompass.
A Tazarotene written confirmation (Tazarotene WC) is an official document issued by a regulatory agency to a Tazarotene manufacturer, verifying that the manufacturing facility of a Tazarotene active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tazarotene APIs or Tazarotene finished pharmaceutical products to another nation, regulatory agencies frequently require a Tazarotene WC (written confirmation) as part of the regulatory process.
click here to find a list of Tazarotene 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 Tazarotene as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tazarotene 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 Tazarotene 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 Tazarotene and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tazarotene NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tazarotene suppliers with NDC on PharmaCompass.
Tazarotene 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 Tazarotene 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 Tazarotene GMP manufacturer or Tazarotene GMP API supplier for your needs.
A Tazarotene CoA (Certificate of Analysis) is a formal document that attests to Tazarotene's compliance with Tazarotene specifications and serves as a tool for batch-level quality control.
Tazarotene CoA mostly includes findings from lab analyses of a specific batch. For each Tazarotene 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.
Tazarotene may be tested according to a variety of international standards, such as European Pharmacopoeia (Tazarotene EP), Tazarotene JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tazarotene USP).
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
