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