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API SUPPLIERS
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USDMF
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Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a w...
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Pancreatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pancreatin, including repackagers and relabelers. The FDA regulates Pancreatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pancreatin 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 Pancreatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pancreatin supplier is an individual or a company that provides Pancreatin active pharmaceutical ingredient (API) or Pancreatin finished formulations upon request. The Pancreatin suppliers may include Pancreatin API manufacturers, exporters, distributors and traders.
click here to find a list of Pancreatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pancreatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Pancreatin active pharmaceutical ingredient (API) in detail. Different forms of Pancreatin DMFs exist exist since differing nations have different regulations, such as Pancreatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pancreatin DMF submitted to regulatory agencies in the US is known as a USDMF. Pancreatin USDMF includes data on Pancreatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pancreatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pancreatin 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 Pancreatin Drug Master File in Japan (Pancreatin JDMF) empowers Pancreatin 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 Pancreatin JDMF during the approval evaluation for pharmaceutical products. At the time of Pancreatin 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 Pancreatin suppliers with JDMF on PharmaCompass.
Pancreatin 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 Pancreatin 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 Pancreatin GMP manufacturer or Pancreatin GMP API supplier for your needs.
A Pancreatin CoA (Certificate of Analysis) is a formal document that attests to Pancreatin's compliance with Pancreatin specifications and serves as a tool for batch-level quality control.
Pancreatin CoA mostly includes findings from lab analyses of a specific batch. For each Pancreatin 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.
Pancreatin may be tested according to a variety of international standards, such as European Pharmacopoeia (Pancreatin EP), Pancreatin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pancreatin USP).
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