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Looking for 140898-91-5 / Aminolevulinic Acid Hexylester API manufacturers, exporters & distributors?

Aminolevulinic Acid Hexylester manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Aminolevulinic Acid Hexylester 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 Aminolevulinic Acid Hexylester manufacturer or Aminolevulinic Acid Hexylester supplier for your needs.

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

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

API | Excipient name

Aminolevulinic Acid Hexylester

Synonyms

140898-91-5, Hexyl 5-amino-4-oxopentanoate hydrochloride, 5-aminolevulinic acid hexyl ester hydrochloride, Hexaminolevulinate hcl, Cysview, Hexaminolevulinate (hydrochloride)

Cas Number

140898-91-5

Unique Ingredient Identifier (UNII)

D4F329SL1O

About Aminolevulinic Acid Hexylester

Hexaminolevulinate Hydrochloride is the hydrochloride salt form of hexaminolevulinate, a hexyl ester of the heme precursor 5-aminolevulinic acid (ALA) with potential photosensitizing activity. Hexaminolevulinate serves as a precursor of photoactive porphyrins (PAPs), particularly protoporphyrin IX (PpIX), which selectively accumulate in rapidly proliferating cells, such as those seen in tumor tissue. When exposed to blue light, PAPs are activated and emit red light thereby allowing tumor imaging.

HEXAMINOLEVULINATE HYDROCHLORIDE Manufacturers

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

HEXAMINOLEVULINATE HYDROCHLORIDE Suppliers

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

HEXAMINOLEVULINATE HYDROCHLORIDE KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a HEXAMINOLEVULINATE HYDROCHLORIDE Drug Master File in Korea (HEXAMINOLEVULINATE HYDROCHLORIDE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of HEXAMINOLEVULINATE HYDROCHLORIDE. The MFDS reviews the HEXAMINOLEVULINATE HYDROCHLORIDE KDMF as part of the drug registration process and uses the information provided in the HEXAMINOLEVULINATE HYDROCHLORIDE KDMF to evaluate the safety and efficacy of the drug.

After submitting a HEXAMINOLEVULINATE HYDROCHLORIDE KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their HEXAMINOLEVULINATE HYDROCHLORIDE API can apply through the Korea Drug Master File (KDMF).

click here to find a list of HEXAMINOLEVULINATE HYDROCHLORIDE suppliers with KDMF on PharmaCompass.

HEXAMINOLEVULINATE 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 HEXAMINOLEVULINATE HYDROCHLORIDE as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for HEXAMINOLEVULINATE 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 HEXAMINOLEVULINATE 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 HEXAMINOLEVULINATE HYDROCHLORIDE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a HEXAMINOLEVULINATE HYDROCHLORIDE NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of HEXAMINOLEVULINATE HYDROCHLORIDE suppliers with NDC on PharmaCompass.

HEXAMINOLEVULINATE HYDROCHLORIDE GMP

HEXAMINOLEVULINATE 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 HEXAMINOLEVULINATE 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 HEXAMINOLEVULINATE HYDROCHLORIDE GMP manufacturer or HEXAMINOLEVULINATE HYDROCHLORIDE GMP API supplier for your needs.

HEXAMINOLEVULINATE HYDROCHLORIDE CoA

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

HEXAMINOLEVULINATE HYDROCHLORIDE CoA mostly includes findings from lab analyses of a specific batch. For each HEXAMINOLEVULINATE 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.

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