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API SUPPLIERS
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USDMF
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies 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 APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
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 : Complete
Rev. Date : 2015-06-11
Pay. Date : 2014-12-30
DMF Number : 29117
Submission : 2015-03-31
Status :
Type : II
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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
About the Company : Polpharma API, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Su...
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-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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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, Price,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.
PharmaCompass also assists you with knowing the Enzalutamide API Price utilized in the formulation of products. Enzalutamide API Price is not always fixed or binding as the Enzalutamide Price is obtained through a variety of data sources. The Enzalutamide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Enzalutamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enzalutamide, including repackagers and relabelers. The FDA regulates Enzalutamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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 Enzalutamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Enzalutamide supplier is an individual or a company that provides Enzalutamide active pharmaceutical ingredient (API) or Enzalutamide finished formulations upon request. The Enzalutamide suppliers may include Enzalutamide API manufacturers, exporters, distributors and traders.
click here to find a list of Enzalutamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Enzalutamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Enzalutamide active pharmaceutical ingredient (API) in detail. Different forms of Enzalutamide DMFs exist exist since differing nations have different regulations, such as Enzalutamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Enzalutamide DMF submitted to regulatory agencies in the US is known as a USDMF. Enzalutamide USDMF includes data on Enzalutamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Enzalutamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Enzalutamide 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 Enzalutamide Drug Master File in Korea (Enzalutamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Enzalutamide. The MFDS reviews the Enzalutamide KDMF as part of the drug registration process and uses the information provided in the Enzalutamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a 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 Enzalutamide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Enzalutamide suppliers with KDMF on PharmaCompass.
A Enzalutamide written confirmation (Enzalutamide WC) is an official document issued by a regulatory agency to a Enzalutamide manufacturer, verifying that the manufacturing facility of a Enzalutamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Enzalutamide APIs or Enzalutamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Enzalutamide WC (written confirmation) as part of the regulatory process.
click here to find a list of 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 Enzalutamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 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 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 Enzalutamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Enzalutamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Enzalutamide suppliers with NDC on PharmaCompass.
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 Enzalutamide 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 Enzalutamide GMP manufacturer or Enzalutamide GMP API supplier for your needs.
A Enzalutamide CoA (Certificate of Analysis) is a formal document that attests to Enzalutamide's compliance with Enzalutamide specifications and serves as a tool for batch-level quality control.
Enzalutamide CoA mostly includes findings from lab analyses of a specific batch. For each 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.
Enzalutamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Enzalutamide EP), Enzalutamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Enzalutamide USP).
