Synopsis
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CEP/COS
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EU WC
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KDMF
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VMF
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EDQM
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USP
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JP
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Others
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Australia
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South Africa
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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 2...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 25MG BASE
USFDA APPLICATION NUMBER - 203389
DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 7...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 75MG BASE
USFDA APPLICATION NUMBER - 203389
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ABOUT THIS PAGE
61
PharmaCompass offers a list of Cysteamine Bitartrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cysteamine Bitartrate manufacturer or Cysteamine Bitartrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cysteamine Bitartrate manufacturer or Cysteamine Bitartrate supplier.
A Cysteamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cysteamine, including repackagers and relabelers. The FDA regulates Cysteamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cysteamine 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 Cysteamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Cysteamine supplier is an individual or a company that provides Cysteamine active pharmaceutical ingredient (API) or Cysteamine finished formulations upon request. The Cysteamine suppliers may include Cysteamine API manufacturers, exporters, distributors and traders.
click here to find a list of Cysteamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Cysteamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Cysteamine active pharmaceutical ingredient (API) in detail. Different forms of Cysteamine DMFs exist exist since differing nations have different regulations, such as Cysteamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cysteamine DMF submitted to regulatory agencies in the US is known as a USDMF. Cysteamine USDMF includes data on Cysteamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cysteamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cysteamine 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 Cysteamine Drug Master File in Japan (Cysteamine JDMF) empowers Cysteamine 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 Cysteamine JDMF during the approval evaluation for pharmaceutical products. At the time of Cysteamine 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 Cysteamine suppliers with JDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Cysteamine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cysteamine API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Cysteamine as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Cysteamine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cysteamine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cysteamine suppliers with NDC on PharmaCompass.
Cysteamine 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 Cysteamine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cysteamine GMP manufacturer or Cysteamine GMP API supplier for your needs.
A Cysteamine CoA (Certificate of Analysis) is a formal document that attests to Cysteamine's compliance with Cysteamine specifications and serves as a tool for batch-level quality control.
Cysteamine CoA mostly includes findings from lab analyses of a specific batch. For each Cysteamine 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.
Cysteamine may be tested according to a variety of international standards, such as European Pharmacopoeia (Cysteamine EP), Cysteamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cysteamine USP).
