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