Synopsis
0
CEP/COS
0
VMF
DRUG PRODUCT COMPOSITIONS
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Parenteral
Solubilizers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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).
LOOKING FOR A SUPPLIER?
