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API SUPPLIERS
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
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USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2024-07-26
Pay. Date : 2024-05-20
DMF Number : 39935
Submission : 2024-06-06
Status :
Type : II
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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
About the Company : Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling ...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
About the Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
TAPI offers customized CDMO Solutions for API development and manufacturing services.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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Drugs in Development
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ABOUT THIS PAGE
A Clascoterone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clascoterone, including repackagers and relabelers. The FDA regulates Clascoterone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clascoterone 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 Clascoterone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clascoterone supplier is an individual or a company that provides Clascoterone active pharmaceutical ingredient (API) or Clascoterone finished formulations upon request. The Clascoterone suppliers may include Clascoterone API manufacturers, exporters, distributors and traders.
click here to find a list of Clascoterone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Clascoterone DMF (Drug Master File) is a document detailing the whole manufacturing process of Clascoterone active pharmaceutical ingredient (API) in detail. Different forms of Clascoterone DMFs exist exist since differing nations have different regulations, such as Clascoterone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Clascoterone DMF submitted to regulatory agencies in the US is known as a USDMF. Clascoterone USDMF includes data on Clascoterone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clascoterone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Clascoterone suppliers with USDMF 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 Clascoterone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Clascoterone 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 Clascoterone 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 Clascoterone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Clascoterone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Clascoterone suppliers with NDC on PharmaCompass.
Clascoterone 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 Clascoterone 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 Clascoterone GMP manufacturer or Clascoterone GMP API supplier for your needs.
A Clascoterone CoA (Certificate of Analysis) is a formal document that attests to Clascoterone's compliance with Clascoterone specifications and serves as a tool for batch-level quality control.
Clascoterone CoA mostly includes findings from lab analyses of a specific batch. For each Clascoterone 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.
Clascoterone may be tested according to a variety of international standards, such as European Pharmacopoeia (Clascoterone EP), Clascoterone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clascoterone USP).
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