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ABOUT THIS PAGE
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.
click here to find a list of HEXAMINOLEVULINATE HYDROCHLORIDE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
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.
click here to find a list of HEXAMINOLEVULINATE HYDROCHLORIDE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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.
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).
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.
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.
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 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.
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).
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