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ABOUT THIS PAGE
A Polyglactin 910 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polyglactin 910, including repackagers and relabelers. The FDA regulates Polyglactin 910 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polyglactin 910 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 Polyglactin 910 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Polyglactin 910 supplier is an individual or a company that provides Polyglactin 910 active pharmaceutical ingredient (API) or Polyglactin 910 finished formulations upon request. The Polyglactin 910 suppliers may include Polyglactin 910 API manufacturers, exporters, distributors and traders.
click here to find a list of Polyglactin 910 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Polyglactin 910 DMF (Drug Master File) is a document detailing the whole manufacturing process of Polyglactin 910 active pharmaceutical ingredient (API) in detail. Different forms of Polyglactin 910 DMFs exist exist since differing nations have different regulations, such as Polyglactin 910 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Polyglactin 910 DMF submitted to regulatory agencies in the US is known as a USDMF. Polyglactin 910 USDMF includes data on Polyglactin 910's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polyglactin 910 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Polyglactin 910 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 Polyglactin 910 Drug Master File in Japan (Polyglactin 910 JDMF) empowers Polyglactin 910 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 Polyglactin 910 JDMF during the approval evaluation for pharmaceutical products. At the time of Polyglactin 910 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 Polyglactin 910 suppliers with JDMF on PharmaCompass.
Polyglactin 910 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 Polyglactin 910 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 Polyglactin 910 GMP manufacturer or Polyglactin 910 GMP API supplier for your needs.
A Polyglactin 910 CoA (Certificate of Analysis) is a formal document that attests to Polyglactin 910's compliance with Polyglactin 910 specifications and serves as a tool for batch-level quality control.
Polyglactin 910 CoA mostly includes findings from lab analyses of a specific batch. For each Polyglactin 910 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.
Polyglactin 910 may be tested according to a variety of international standards, such as European Pharmacopoeia (Polyglactin 910 EP), Polyglactin 910 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Polyglactin 910 USP).
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