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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
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39560
Submission : 2024-04-04
Status :
Type : II
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35618
Submission : 2021-04-28
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41429
Submission : 2025-03-27
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-11
Pay. Date : 2014-12-30
DMF Number : 29117
Submission : 2015-03-31
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
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Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Date of Issue : 2025-08-22
Valid Till : 2028-08-21
Written Confirmation Number : WC-0099
Address of the Firm : Plot No.E-50, 50/1 and 59/1, Unit-IV, MIDC, Tarapur-401506, Taluka: Palghar, Dis...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2025-07-15
Valid Till : 2028-07-07
Written Confirmation Number : WC-0067
Address of the Firm : Chemical Technical Operation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Hanmi Pharmaceutical Co., Ltd.
Registration Date : 2025-10-14
Registration Number : Su574-21-ND(1)
Manufacturer Name : Dr. Reddy's Laboratories Lim...
Manufacturer Address : CTO Unit-VI, APIIC Industrial Estate, Pydibhimavaram Village, Ranasthalam Mandal, Sri...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Pamire Co., Ltd.
Registration Date : 2022-05-09
Registration Number : Su574-21-ND
Manufacturer Name : Dr. Reddy's Laboratories Lim...
Manufacturer Address : CTO Unit-VI, APIIC Industrial Estate, Pydibhimavaram Village, Ranasthalam Mandal, Sri...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Cosmax Pharma Co., Ltd.
Registration Date : 2026-02-26
Registration Number : Su574-21-ND(2)
Manufacturer Name : Dr. Reddy's Laboratories Lim...
Manufacturer Address : CTO Unit-VI, APIIC Industrial Estate, Pydibhimavaram Village, Ranasthalam Mandal, Sri...
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
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
4-Bromo-2-fluoro-N-methyl-benzamide
CAS Number : 749927-69-3
End Use API : Enzalutamide
About The Company : Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Deri...
Rampex Labs – Simplifying Synthesis with Innovation, Quality, and Commitment to Global Pharmaceutical Excellence.
4-Bromo-2-Fluoro-N-Methylbenzamide
CAS Number : 749927-69-3
End Use API : Enzalutamide
About The Company : Rampex Labs, founded in 2004, is a fully cGMP-compliant pharmaceutical manufacturer with two USFDA-approved facilities in Hyderabad and Vizag, India. The Hydera...
Rampex Labs – Simplifying Synthesis with Innovation, Quality, and Commitment to Global Pharmaceutical Excellence.
CAS Number : 112704-79-7
End Use API : Enzalutamide
About The Company : Rampex Labs, founded in 2004, is a fully cGMP-compliant pharmaceutical manufacturer with two USFDA-approved facilities in Hyderabad and Vizag, India. The Hydera...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : PRESCRIPTION
Registration Country : Canada
Brand Name : REDDY-ENZALUTAMIDE
Dosage Form : CAPSULE
Dosage Strength : 40MG
Packaging :
Approval Date :
Application Number : 2558424
Regulatory Info : PRESCRIPTION
Registration Country : Canada
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US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
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 MDV3100 Enzalutamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MDV3100 Enzalutamide, including repackagers and relabelers. The FDA regulates MDV3100 Enzalutamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MDV3100 Enzalutamide 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 MDV3100 Enzalutamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A MDV3100 Enzalutamide supplier is an individual or a company that provides MDV3100 Enzalutamide active pharmaceutical ingredient (API) or MDV3100 Enzalutamide finished formulations upon request. The MDV3100 Enzalutamide suppliers may include MDV3100 Enzalutamide API manufacturers, exporters, distributors and traders.
click here to find a list of MDV3100 Enzalutamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A MDV3100 Enzalutamide DMF (Drug Master File) is a document detailing the whole manufacturing process of MDV3100 Enzalutamide active pharmaceutical ingredient (API) in detail. Different forms of MDV3100 Enzalutamide DMFs exist exist since differing nations have different regulations, such as MDV3100 Enzalutamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MDV3100 Enzalutamide DMF submitted to regulatory agencies in the US is known as a USDMF. MDV3100 Enzalutamide USDMF includes data on MDV3100 Enzalutamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MDV3100 Enzalutamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of MDV3100 Enzalutamide 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 MDV3100 Enzalutamide Drug Master File in Japan (MDV3100 Enzalutamide JDMF) empowers MDV3100 Enzalutamide 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 MDV3100 Enzalutamide JDMF during the approval evaluation for pharmaceutical products. At the time of MDV3100 Enzalutamide 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 MDV3100 Enzalutamide 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 MDV3100 Enzalutamide Drug Master File in Korea (MDV3100 Enzalutamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of MDV3100 Enzalutamide. The MFDS reviews the MDV3100 Enzalutamide KDMF as part of the drug registration process and uses the information provided in the MDV3100 Enzalutamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a MDV3100 Enzalutamide 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 MDV3100 Enzalutamide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of MDV3100 Enzalutamide suppliers with KDMF on PharmaCompass.
A MDV3100 Enzalutamide written confirmation (MDV3100 Enzalutamide WC) is an official document issued by a regulatory agency to a MDV3100 Enzalutamide manufacturer, verifying that the manufacturing facility of a MDV3100 Enzalutamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting MDV3100 Enzalutamide APIs or MDV3100 Enzalutamide finished pharmaceutical products to another nation, regulatory agencies frequently require a MDV3100 Enzalutamide WC (written confirmation) as part of the regulatory process.
click here to find a list of MDV3100 Enzalutamide 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 MDV3100 Enzalutamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for MDV3100 Enzalutamide 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 MDV3100 Enzalutamide 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 MDV3100 Enzalutamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a MDV3100 Enzalutamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of MDV3100 Enzalutamide suppliers with NDC on PharmaCompass.
MDV3100 Enzalutamide 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 MDV3100 Enzalutamide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right MDV3100 Enzalutamide GMP manufacturer or MDV3100 Enzalutamide GMP API supplier for your needs.
A MDV3100 Enzalutamide CoA (Certificate of Analysis) is a formal document that attests to MDV3100 Enzalutamide's compliance with MDV3100 Enzalutamide specifications and serves as a tool for batch-level quality control.
MDV3100 Enzalutamide CoA mostly includes findings from lab analyses of a specific batch. For each MDV3100 Enzalutamide 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.
MDV3100 Enzalutamide may be tested according to a variety of international standards, such as European Pharmacopoeia (MDV3100 Enzalutamide EP), MDV3100 Enzalutamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MDV3100 Enzalutamide USP).
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