API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
0
Other Suppliers
0
0
0
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
43
PharmaCompass offers a list of Suprofen 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 Suprofen manufacturer or Suprofen supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Suprofen manufacturer or Suprofen supplier.
PharmaCompass also assists you with knowing the Suprofen API Price utilized in the formulation of products. Suprofen API Price is not always fixed or binding as the Suprofen Price is obtained through a variety of data sources. The Suprofen Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Suprofen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Suprofen, including repackagers and relabelers. The FDA regulates Suprofen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Suprofen API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Suprofen supplier is an individual or a company that provides Suprofen active pharmaceutical ingredient (API) or Suprofen finished formulations upon request. The Suprofen suppliers may include Suprofen API manufacturers, exporters, distributors and traders.
click here to find a list of Suprofen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Suprofen DMF (Drug Master File) is a document detailing the whole manufacturing process of Suprofen active pharmaceutical ingredient (API) in detail. Different forms of Suprofen DMFs exist exist since differing nations have different regulations, such as Suprofen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Suprofen DMF submitted to regulatory agencies in the US is known as a USDMF. Suprofen USDMF includes data on Suprofen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Suprofen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Suprofen 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 Suprofen Drug Master File in Japan (Suprofen JDMF) empowers Suprofen 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 Suprofen JDMF during the approval evaluation for pharmaceutical products. At the time of Suprofen 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 Suprofen suppliers with JDMF on PharmaCompass.
Suprofen 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 Suprofen 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 Suprofen GMP manufacturer or Suprofen GMP API supplier for your needs.
A Suprofen CoA (Certificate of Analysis) is a formal document that attests to Suprofen's compliance with Suprofen specifications and serves as a tool for batch-level quality control.
Suprofen CoA mostly includes findings from lab analyses of a specific batch. For each Suprofen 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.
Suprofen may be tested according to a variety of international standards, such as European Pharmacopoeia (Suprofen EP), Suprofen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Suprofen USP).