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PharmaCompass offers a list of Cysteamine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Cysteamine Hydrochloride manufacturer or Cysteamine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cysteamine Hydrochloride manufacturer or Cysteamine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Cysteamine Hydrochloride API Price utilized in the formulation of products. Cysteamine Hydrochloride API Price is not always fixed or binding as the Cysteamine Hydrochloride Price is obtained through a variety of data sources. The Cysteamine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 1-Aminoethane-2-thiol hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-Aminoethane-2-thiol hydrochloride, including repackagers and relabelers. The FDA regulates 1-Aminoethane-2-thiol hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-Aminoethane-2-thiol hydrochloride 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 1-Aminoethane-2-thiol hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 1-Aminoethane-2-thiol hydrochloride supplier is an individual or a company that provides 1-Aminoethane-2-thiol hydrochloride active pharmaceutical ingredient (API) or 1-Aminoethane-2-thiol hydrochloride finished formulations upon request. The 1-Aminoethane-2-thiol hydrochloride suppliers may include 1-Aminoethane-2-thiol hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of 1-Aminoethane-2-thiol hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 1-Aminoethane-2-thiol hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of 1-Aminoethane-2-thiol hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of 1-Aminoethane-2-thiol hydrochloride DMFs exist exist since differing nations have different regulations, such as 1-Aminoethane-2-thiol hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1-Aminoethane-2-thiol hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. 1-Aminoethane-2-thiol hydrochloride USDMF includes data on 1-Aminoethane-2-thiol hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1-Aminoethane-2-thiol hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 1-Aminoethane-2-thiol hydrochloride Drug Master File in Japan (1-Aminoethane-2-thiol hydrochloride JDMF) empowers 1-Aminoethane-2-thiol hydrochloride 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 1-Aminoethane-2-thiol hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of 1-Aminoethane-2-thiol hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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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 1-Aminoethane-2-thiol hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 1-Aminoethane-2-thiol hydrochloride 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 1-Aminoethane-2-thiol hydrochloride 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 1-Aminoethane-2-thiol hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1-Aminoethane-2-thiol hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
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1-Aminoethane-2-thiol hydrochloride 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 1-Aminoethane-2-thiol hydrochloride 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 1-Aminoethane-2-thiol hydrochloride GMP manufacturer or 1-Aminoethane-2-thiol hydrochloride GMP API supplier for your needs.
A 1-Aminoethane-2-thiol hydrochloride CoA (Certificate of Analysis) is a formal document that attests to 1-Aminoethane-2-thiol hydrochloride's compliance with 1-Aminoethane-2-thiol hydrochloride specifications and serves as a tool for batch-level quality control.
1-Aminoethane-2-thiol hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each 1-Aminoethane-2-thiol hydrochloride 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.
1-Aminoethane-2-thiol hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (1-Aminoethane-2-thiol hydrochloride EP), 1-Aminoethane-2-thiol hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1-Aminoethane-2-thiol hydrochloride USP).