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ABOUT THIS PAGE
A Beraprost Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Beraprost Sodium, including repackagers and relabelers. The FDA regulates Beraprost Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Beraprost 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 Beraprost Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Beraprost Sodium supplier is an individual or a company that provides Beraprost Sodium active pharmaceutical ingredient (API) or Beraprost Sodium finished formulations upon request. The Beraprost Sodium suppliers may include Beraprost Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Beraprost Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Beraprost Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Beraprost Sodium active pharmaceutical ingredient (API) in detail. Different forms of Beraprost Sodium DMFs exist exist since differing nations have different regulations, such as Beraprost Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Beraprost Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Beraprost Sodium USDMF includes data on Beraprost Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Beraprost Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Beraprost 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 Beraprost Sodium Drug Master File in Japan (Beraprost Sodium JDMF) empowers Beraprost 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 Beraprost Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Beraprost 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 Beraprost Sodium 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 Sodium Drug Master File in Korea (Beraprost Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Beraprost Sodium. The MFDS reviews the Beraprost Sodium KDMF as part of the drug registration process and uses the information provided in the Beraprost Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Beraprost Sodium 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 Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Beraprost Sodium suppliers with KDMF on PharmaCompass.
Beraprost 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 Beraprost 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 Beraprost Sodium GMP manufacturer or Beraprost Sodium GMP API supplier for your needs.
A Beraprost Sodium CoA (Certificate of Analysis) is a formal document that attests to Beraprost Sodium's compliance with Beraprost Sodium specifications and serves as a tool for batch-level quality control.
Beraprost Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Beraprost 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.
Beraprost Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Beraprost Sodium EP), Beraprost Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Beraprost Sodium USP).
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