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DRUG PRODUCT COMPOSITIONS
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API SUPPLIERS
Cayman Pharma is Europe's most reliable and versatile source for Prostaglandin APIs//FDA approved.
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KDMF
CA,
Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.
Chirogate is a professional Prostaglandin manufacturer.
NDC
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
JDMF
NDC
ASMF, CN
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Veranova: A CDMO that manages complexity with confidence.
Jai Radhe Sales is your partner for all your sourcing needs.
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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USDMF
Cayman Pharma is Europe's most reliable and versatile source for Prostaglandin APIs//FDA approved.
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-12
Pay. Date : 2013-02-11
DMF Number : 24353
Submission : 2011-01-10
Status :
Type : II
Chirogate is a professional Prostaglandin manufacturer.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21382
Submission : 2008-02-26
Status :
Type : II
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34360
Submission : 2019-12-10
Status :
Type : II
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-20
Pay. Date : 2015-12-08
DMF Number : 29560
Submission : 2015-07-17
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20911
Submission : 2007-10-04
Status :
Type : II
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API Imports and Exports
Drugs in Development
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Bimatoprost 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 Bimatoprost manufacturer or Bimatoprost supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bimatoprost manufacturer or Bimatoprost supplier.
PharmaCompass also assists you with knowing the Bimatoprost API Price utilized in the formulation of products. Bimatoprost API Price is not always fixed or binding as the Bimatoprost Price is obtained through a variety of data sources. The Bimatoprost Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bimatoprost manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bimatoprost, including repackagers and relabelers. The FDA regulates Bimatoprost manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bimatoprost 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 Bimatoprost manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bimatoprost supplier is an individual or a company that provides Bimatoprost active pharmaceutical ingredient (API) or Bimatoprost finished formulations upon request. The Bimatoprost suppliers may include Bimatoprost API manufacturers, exporters, distributors and traders.
click here to find a list of Bimatoprost suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bimatoprost DMF (Drug Master File) is a document detailing the whole manufacturing process of Bimatoprost active pharmaceutical ingredient (API) in detail. Different forms of Bimatoprost DMFs exist exist since differing nations have different regulations, such as Bimatoprost USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bimatoprost DMF submitted to regulatory agencies in the US is known as a USDMF. Bimatoprost USDMF includes data on Bimatoprost's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bimatoprost USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bimatoprost 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 Bimatoprost Drug Master File in Japan (Bimatoprost JDMF) empowers Bimatoprost 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 Bimatoprost JDMF during the approval evaluation for pharmaceutical products. At the time of Bimatoprost 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 Bimatoprost 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 Bimatoprost Drug Master File in Korea (Bimatoprost KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bimatoprost. The MFDS reviews the Bimatoprost KDMF as part of the drug registration process and uses the information provided in the Bimatoprost KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bimatoprost 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 Bimatoprost API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bimatoprost suppliers with KDMF on PharmaCompass.
A Bimatoprost written confirmation (Bimatoprost WC) is an official document issued by a regulatory agency to a Bimatoprost manufacturer, verifying that the manufacturing facility of a Bimatoprost active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bimatoprost APIs or Bimatoprost finished pharmaceutical products to another nation, regulatory agencies frequently require a Bimatoprost WC (written confirmation) as part of the regulatory process.
click here to find a list of Bimatoprost 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 Bimatoprost as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bimatoprost 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 Bimatoprost 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 Bimatoprost and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bimatoprost NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bimatoprost suppliers with NDC on PharmaCompass.
Bimatoprost 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 Bimatoprost 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 Bimatoprost GMP manufacturer or Bimatoprost GMP API supplier for your needs.
A Bimatoprost CoA (Certificate of Analysis) is a formal document that attests to Bimatoprost's compliance with Bimatoprost specifications and serves as a tool for batch-level quality control.
Bimatoprost CoA mostly includes findings from lab analyses of a specific batch. For each Bimatoprost 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.
Bimatoprost may be tested according to a variety of international standards, such as European Pharmacopoeia (Bimatoprost EP), Bimatoprost JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bimatoprost USP).
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