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Kirsch Pharma
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Parenteral
Excipient Details : Used as an osmolarity agent in culture media, tonicity adjuster in ophthalmics and parenterals solutions.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : Sodium Chloride Excipient
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Parenteral
Excipient Details : Used as an osmolarity agent in culture media, tonicity adjuster in ophthalmics and parenterals solutions.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...
Ingredient(s) : Sodium Chloride Excipient
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ABOUT THIS PAGE
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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 Cysteamine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cysteamine Hydrochloride, including repackagers and relabelers. The FDA regulates Cysteamine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cysteamine 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 Cysteamine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cysteamine Hydrochloride supplier is an individual or a company that provides Cysteamine Hydrochloride active pharmaceutical ingredient (API) or Cysteamine Hydrochloride finished formulations upon request. The Cysteamine Hydrochloride suppliers may include Cysteamine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Cysteamine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cysteamine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Cysteamine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Cysteamine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Cysteamine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cysteamine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Cysteamine Hydrochloride USDMF includes data on Cysteamine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cysteamine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cysteamine Hydrochloride 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 Hydrochloride Drug Master File in Japan (Cysteamine Hydrochloride JDMF) empowers Cysteamine 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 Cysteamine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Cysteamine Hydrochloride 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 Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cysteamine 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 Cysteamine 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 Cysteamine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cysteamine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cysteamine Hydrochloride suppliers with NDC on PharmaCompass.
Cysteamine 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 Cysteamine 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 Cysteamine Hydrochloride GMP manufacturer or Cysteamine Hydrochloride GMP API supplier for your needs.
A Cysteamine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Cysteamine Hydrochloride's compliance with Cysteamine Hydrochloride specifications and serves as a tool for batch-level quality control.
Cysteamine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Cysteamine 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.
Cysteamine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Cysteamine Hydrochloride EP), Cysteamine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cysteamine Hydrochloride USP).
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