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API SUPPLIERS
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USDMF
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Chirogate is a professional Prostaglandin manufacturer.
About the Company : Chirogate, established in 1999, is a leading supplier of niche-market molecules, specializing in prostaglandins. With a focus on quality and compliance, Chirogate has built a reput...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...
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ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
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PharmaCompass offers a list of Beraprost 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 Beraprost Sodium manufacturer or Beraprost Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Beraprost Sodium manufacturer or Beraprost Sodium supplier.
PharmaCompass also assists you with knowing the Beraprost Sodium API Price utilized in the formulation of products. Beraprost Sodium API Price is not always fixed or binding as the Beraprost Sodium Price is obtained through a variety of data sources. The Beraprost Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Beraprost manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Beraprost, including repackagers and relabelers. The FDA regulates Beraprost manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Beraprost 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 Beraprost manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Beraprost supplier is an individual or a company that provides Beraprost active pharmaceutical ingredient (API) or Beraprost finished formulations upon request. The Beraprost suppliers may include Beraprost API manufacturers, exporters, distributors and traders.
click here to find a list of Beraprost suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Beraprost DMF (Drug Master File) is a document detailing the whole manufacturing process of Beraprost active pharmaceutical ingredient (API) in detail. Different forms of Beraprost DMFs exist exist since differing nations have different regulations, such as Beraprost USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Beraprost DMF submitted to regulatory agencies in the US is known as a USDMF. Beraprost USDMF includes data on Beraprost's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Beraprost USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Beraprost 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 Beraprost Drug Master File in Japan (Beraprost JDMF) empowers Beraprost 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 Beraprost JDMF during the approval evaluation for pharmaceutical products. At the time of Beraprost 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 Beraprost 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 Beraprost Drug Master File in Korea (Beraprost KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Beraprost. The MFDS reviews the Beraprost KDMF as part of the drug registration process and uses the information provided in the Beraprost KDMF to evaluate the safety and efficacy of the drug.
After submitting a Beraprost 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 Beraprost API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Beraprost suppliers with KDMF on PharmaCompass.
Beraprost 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 Beraprost 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 Beraprost GMP manufacturer or Beraprost GMP API supplier for your needs.
A Beraprost CoA (Certificate of Analysis) is a formal document that attests to Beraprost's compliance with Beraprost specifications and serves as a tool for batch-level quality control.
Beraprost CoA mostly includes findings from lab analyses of a specific batch. For each Beraprost 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.
Beraprost may be tested according to a variety of international standards, such as European Pharmacopoeia (Beraprost EP), Beraprost JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Beraprost USP).
