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API SUPPLIERS
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Aspen API. More than just an API™
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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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, & custom-made solutions to our customers.
About the Company : Founded in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. The company supports customers in the development, scale-up, and man...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
About the Company : Symbiotec, based in Indore, India, is a leading API manufacturer specializing in cortico-steroids and steroid-hormone APIs since 1995. Focused on R&D, sustainability, and innovatio...
Aspen API. More than just an API™
About the Company : Aspen API is a cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. The company supplies a broad portfolio of over 58 high-qual...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Clascoterone 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 Clascoterone manufacturer or Clascoterone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Clascoterone manufacturer or Clascoterone supplier.
PharmaCompass also assists you with knowing the Clascoterone API Price utilized in the formulation of products. Clascoterone API Price is not always fixed or binding as the Clascoterone Price is obtained through a variety of data sources. The Clascoterone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A breezula manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of breezula, including repackagers and relabelers. The FDA regulates breezula manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. breezula 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 breezula manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A breezula supplier is an individual or a company that provides breezula active pharmaceutical ingredient (API) or breezula finished formulations upon request. The breezula suppliers may include breezula API manufacturers, exporters, distributors and traders.
click here to find a list of breezula suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A breezula DMF (Drug Master File) is a document detailing the whole manufacturing process of breezula active pharmaceutical ingredient (API) in detail. Different forms of breezula DMFs exist exist since differing nations have different regulations, such as breezula USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A breezula DMF submitted to regulatory agencies in the US is known as a USDMF. breezula USDMF includes data on breezula's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The breezula USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of breezula 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 breezula Drug Master File in Korea (breezula KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of breezula. The MFDS reviews the breezula KDMF as part of the drug registration process and uses the information provided in the breezula KDMF to evaluate the safety and efficacy of the drug.
After submitting a breezula 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 breezula API can apply through the Korea Drug Master File (KDMF).
click here to find a list of breezula suppliers with KDMF 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 breezula as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for breezula 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 breezula 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 breezula and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a breezula NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of breezula suppliers with NDC on PharmaCompass.
breezula 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 breezula 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 breezula GMP manufacturer or breezula GMP API supplier for your needs.
A breezula CoA (Certificate of Analysis) is a formal document that attests to breezula's compliance with breezula specifications and serves as a tool for batch-level quality control.
breezula CoA mostly includes findings from lab analyses of a specific batch. For each breezula 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.
breezula may be tested according to a variety of international standards, such as European Pharmacopoeia (breezula EP), breezula JP (Japanese Pharmacopeia) and the US Pharmacopoeia (breezula USP).
