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Looking for 161262-45-9 / Amotosalen hydrochloride API manufacturers, exporters & distributors?

Amotosalen hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Amotosalen 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 Amotosalen hydrochloride manufacturer or Amotosalen hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amotosalen hydrochloride manufacturer or Amotosalen hydrochloride supplier.

PharmaCompass also assists you with knowing the Amotosalen hydrochloride API Price utilized in the formulation of products. Amotosalen hydrochloride API Price is not always fixed or binding as the Amotosalen hydrochloride Price is obtained through a variety of data sources. The Amotosalen hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Amotosalen hydrochloride

Synonyms

Amotosalen hcl, 161262-45-9, S-59, Amotosalen (hydrochloride), 7h-furo(3,2-g)(1)benzopyran-7-one, 3-((2-aminoethoxy)methyl)-2,5,9-trimethyl-, hydrochloride, Amotosalen hydrochloride (usan)

Cas Number

161262-45-9

Unique Ingredient Identifier (UNII)

67B255SI5F

About Amotosalen hydrochloride

Amotosalen Hydrochloride is the hydrochloride salt form of amotosalen, a synthetic psoralen and light-activated DNA, RNA crosslinking agent, with protective activity against pathogens such as bacteria, viruses, protozoa, and leukocytes. Prior to administration amotosalen is added to plasma and platelets, then in vivo the agent penetrates pathogens and targets DNA and RNA. Upon activation by ultraviolet A light, this agent is able to form interstrand DNA and RNA crosslinks and prevents replication. Inactivation of leukocytes can prevent graft versus host disease upon transfusion.

Amotosalen hydrochloride Manufacturers

A Amotosalen hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amotosalen hydrochloride, including repackagers and relabelers. The FDA regulates Amotosalen hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amotosalen 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.

Amotosalen hydrochloride Suppliers

A Amotosalen hydrochloride supplier is an individual or a company that provides Amotosalen hydrochloride active pharmaceutical ingredient (API) or Amotosalen hydrochloride finished formulations upon request. The Amotosalen hydrochloride suppliers may include Amotosalen hydrochloride API manufacturers, exporters, distributors and traders.

Amotosalen hydrochloride NDC

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 Amotosalen hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Amotosalen hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Amotosalen 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Amotosalen hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amotosalen hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Amotosalen hydrochloride suppliers with NDC on PharmaCompass.

Amotosalen hydrochloride GMP

Amotosalen 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 Amotosalen 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 Amotosalen hydrochloride GMP manufacturer or Amotosalen hydrochloride GMP API supplier for your needs.

Amotosalen hydrochloride CoA

A Amotosalen hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Amotosalen hydrochloride's compliance with Amotosalen hydrochloride specifications and serves as a tool for batch-level quality control.

Amotosalen hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Amotosalen 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.

Amotosalen hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Amotosalen hydrochloride EP), Amotosalen hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amotosalen hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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