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API SUPPLIERS
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USDMF
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38922
Submission : 2023-10-18
Status :
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-17
Pay. Date : 2013-07-09
DMF Number : 24521
Submission : 2011-05-20
Status :
Type : II
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Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Registration Number : 230MF10078
Registrant's Address : Na vlcinci 16/3 Klasterni Hradisko 77900 Olomouc Czech Republic
Initial Date of Registration : 2018-07-03
Latest Date of Registration : 2018-07-03
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Registration Number : 306MF10119
Registrant's Address : Na vlcinci 16/3 Klasterni Hradisko 77900 Olomouc Czech Republic
Initial Date of Registration : 2024-09-03
Latest Date of Registration : 2024-09-03
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ABOUT THIS PAGE
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PharmaCompass offers a list of Bromfenac Sodium 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 Bromfenac Sodium manufacturer or Bromfenac Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bromfenac Sodium manufacturer or Bromfenac Sodium supplier.
PharmaCompass also assists you with knowing the Bromfenac Sodium API Price utilized in the formulation of products. Bromfenac Sodium API Price is not always fixed or binding as the Bromfenac Sodium Price is obtained through a variety of data sources. The Bromfenac Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bromfenac Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bromfenac Sodium, including repackagers and relabelers. The FDA regulates Bromfenac Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bromfenac Sodium 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 Bromfenac Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bromfenac Sodium supplier is an individual or a company that provides Bromfenac Sodium active pharmaceutical ingredient (API) or Bromfenac Sodium finished formulations upon request. The Bromfenac Sodium suppliers may include Bromfenac Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Bromfenac Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bromfenac Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Bromfenac Sodium active pharmaceutical ingredient (API) in detail. Different forms of Bromfenac Sodium DMFs exist exist since differing nations have different regulations, such as Bromfenac Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bromfenac Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Bromfenac Sodium USDMF includes data on Bromfenac Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bromfenac Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bromfenac Sodium 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 Bromfenac Sodium Drug Master File in Japan (Bromfenac Sodium JDMF) empowers Bromfenac Sodium 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 Bromfenac Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Bromfenac Sodium 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 Bromfenac Sodium suppliers with JDMF on PharmaCompass.
A Bromfenac Sodium written confirmation (Bromfenac Sodium WC) is an official document issued by a regulatory agency to a Bromfenac Sodium manufacturer, verifying that the manufacturing facility of a Bromfenac Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bromfenac Sodium APIs or Bromfenac Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Bromfenac Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Bromfenac Sodium 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 Bromfenac Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bromfenac Sodium 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 Bromfenac Sodium 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 Bromfenac Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bromfenac Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bromfenac Sodium suppliers with NDC on PharmaCompass.
Bromfenac Sodium 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 Bromfenac Sodium 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 Bromfenac Sodium GMP manufacturer or Bromfenac Sodium GMP API supplier for your needs.
A Bromfenac Sodium CoA (Certificate of Analysis) is a formal document that attests to Bromfenac Sodium's compliance with Bromfenac Sodium specifications and serves as a tool for batch-level quality control.
Bromfenac Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Bromfenac Sodium 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.
Bromfenac Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Bromfenac Sodium EP), Bromfenac Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bromfenac Sodium USP).
