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API SUPPLIERS
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Evonik Health Care is the innovation hub for leading life science companies
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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US Patents
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ABOUT THIS PAGE
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PharmaCompass offers a list of Enzalutamide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Enzalutamide manufacturer or Enzalutamide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Enzalutamide manufacturer or Enzalutamide supplier.
A XTANDI manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of XTANDI, including repackagers and relabelers. The FDA regulates XTANDI manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. XTANDI 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 XTANDI manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A XTANDI supplier is an individual or a company that provides XTANDI active pharmaceutical ingredient (API) or XTANDI finished formulations upon request. The XTANDI suppliers may include XTANDI API manufacturers, exporters, distributors and traders.
click here to find a list of XTANDI suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A XTANDI DMF (Drug Master File) is a document detailing the whole manufacturing process of XTANDI active pharmaceutical ingredient (API) in detail. Different forms of XTANDI DMFs exist exist since differing nations have different regulations, such as XTANDI USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A XTANDI DMF submitted to regulatory agencies in the US is known as a USDMF. XTANDI USDMF includes data on XTANDI's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The XTANDI USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of XTANDI suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The XTANDI Drug Master File in Japan (XTANDI JDMF) empowers XTANDI API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the XTANDI JDMF during the approval evaluation for pharmaceutical products. At the time of XTANDI JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of XTANDI suppliers with JDMF 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 XTANDI Drug Master File in Korea (XTANDI KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of XTANDI. The MFDS reviews the XTANDI KDMF as part of the drug registration process and uses the information provided in the XTANDI KDMF to evaluate the safety and efficacy of the drug.
After submitting a XTANDI 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 XTANDI API can apply through the Korea Drug Master File (KDMF).
click here to find a list of XTANDI suppliers with KDMF on PharmaCompass.
A XTANDI written confirmation (XTANDI WC) is an official document issued by a regulatory agency to a XTANDI manufacturer, verifying that the manufacturing facility of a XTANDI active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting XTANDI APIs or XTANDI finished pharmaceutical products to another nation, regulatory agencies frequently require a XTANDI WC (written confirmation) as part of the regulatory process.
click here to find a list of XTANDI 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 XTANDI as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for XTANDI 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 XTANDI 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 XTANDI and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a XTANDI NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of XTANDI suppliers with NDC on PharmaCompass.
XTANDI 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 XTANDI GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right XTANDI GMP manufacturer or XTANDI GMP API supplier for your needs.
A XTANDI CoA (Certificate of Analysis) is a formal document that attests to XTANDI's compliance with XTANDI specifications and serves as a tool for batch-level quality control.
XTANDI CoA mostly includes findings from lab analyses of a specific batch. For each XTANDI 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.
XTANDI may be tested according to a variety of international standards, such as European Pharmacopoeia (XTANDI EP), XTANDI JP (Japanese Pharmacopeia) and the US Pharmacopoeia (XTANDI USP).
