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