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API SUPPLIERS
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
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Drugs in Development
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18 Mar 2020
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REF. STANDARDS & IMPURITIES
USP
ABOUT THIS PAGE
A Maltodextrin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Maltodextrin, including repackagers and relabelers. The FDA regulates Maltodextrin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Maltodextrin 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 Maltodextrin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Maltodextrin supplier is an individual or a company that provides Maltodextrin active pharmaceutical ingredient (API) or Maltodextrin finished formulations upon request. The Maltodextrin suppliers may include Maltodextrin API manufacturers, exporters, distributors and traders.
click here to find a list of Maltodextrin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Maltodextrin DMF (Drug Master File) is a document detailing the whole manufacturing process of Maltodextrin active pharmaceutical ingredient (API) in detail. Different forms of Maltodextrin DMFs exist exist since differing nations have different regulations, such as Maltodextrin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Maltodextrin DMF submitted to regulatory agencies in the US is known as a USDMF. Maltodextrin USDMF includes data on Maltodextrin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Maltodextrin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Maltodextrin 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 Maltodextrin Drug Master File in Japan (Maltodextrin JDMF) empowers Maltodextrin 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 Maltodextrin JDMF during the approval evaluation for pharmaceutical products. At the time of Maltodextrin 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 Maltodextrin suppliers with JDMF on PharmaCompass.
Maltodextrin 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 Maltodextrin 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 Maltodextrin GMP manufacturer or Maltodextrin GMP API supplier for your needs.
A Maltodextrin CoA (Certificate of Analysis) is a formal document that attests to Maltodextrin's compliance with Maltodextrin specifications and serves as a tool for batch-level quality control.
Maltodextrin CoA mostly includes findings from lab analyses of a specific batch. For each Maltodextrin 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.
Maltodextrin may be tested according to a variety of international standards, such as European Pharmacopoeia (Maltodextrin EP), Maltodextrin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Maltodextrin USP).
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