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API SUPPLIERS
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USDMF
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ABOUT THIS PAGE
A LORCASERIN HYDROCHLORIDE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LORCASERIN HYDROCHLORIDE, including repackagers and relabelers. The FDA regulates LORCASERIN HYDROCHLORIDE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LORCASERIN 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 LORCASERIN HYDROCHLORIDE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A LORCASERIN HYDROCHLORIDE supplier is an individual or a company that provides LORCASERIN HYDROCHLORIDE active pharmaceutical ingredient (API) or LORCASERIN HYDROCHLORIDE finished formulations upon request. The LORCASERIN HYDROCHLORIDE suppliers may include LORCASERIN HYDROCHLORIDE API manufacturers, exporters, distributors and traders.
click here to find a list of LORCASERIN HYDROCHLORIDE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A LORCASERIN HYDROCHLORIDE DMF (Drug Master File) is a document detailing the whole manufacturing process of LORCASERIN HYDROCHLORIDE active pharmaceutical ingredient (API) in detail. Different forms of LORCASERIN HYDROCHLORIDE DMFs exist exist since differing nations have different regulations, such as LORCASERIN HYDROCHLORIDE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LORCASERIN HYDROCHLORIDE DMF submitted to regulatory agencies in the US is known as a USDMF. LORCASERIN HYDROCHLORIDE USDMF includes data on LORCASERIN HYDROCHLORIDE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LORCASERIN HYDROCHLORIDE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of LORCASERIN HYDROCHLORIDE suppliers with USDMF 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 LORCASERIN HYDROCHLORIDE Drug Master File in Korea (LORCASERIN HYDROCHLORIDE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of LORCASERIN HYDROCHLORIDE. The MFDS reviews the LORCASERIN HYDROCHLORIDE KDMF as part of the drug registration process and uses the information provided in the LORCASERIN HYDROCHLORIDE KDMF to evaluate the safety and efficacy of the drug.
After submitting a LORCASERIN 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 LORCASERIN HYDROCHLORIDE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of LORCASERIN HYDROCHLORIDE suppliers with KDMF on PharmaCompass.
A LORCASERIN HYDROCHLORIDE written confirmation (LORCASERIN HYDROCHLORIDE WC) is an official document issued by a regulatory agency to a LORCASERIN HYDROCHLORIDE manufacturer, verifying that the manufacturing facility of a LORCASERIN HYDROCHLORIDE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting LORCASERIN HYDROCHLORIDE APIs or LORCASERIN HYDROCHLORIDE finished pharmaceutical products to another nation, regulatory agencies frequently require a LORCASERIN HYDROCHLORIDE WC (written confirmation) as part of the regulatory process.
click here to find a list of LORCASERIN HYDROCHLORIDE suppliers with Written Confirmation (WC) 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 LORCASERIN HYDROCHLORIDE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for LORCASERIN 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 LORCASERIN 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 LORCASERIN HYDROCHLORIDE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a LORCASERIN HYDROCHLORIDE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of LORCASERIN HYDROCHLORIDE suppliers with NDC on PharmaCompass.
LORCASERIN 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 LORCASERIN 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 LORCASERIN HYDROCHLORIDE GMP manufacturer or LORCASERIN HYDROCHLORIDE GMP API supplier for your needs.
A LORCASERIN HYDROCHLORIDE CoA (Certificate of Analysis) is a formal document that attests to LORCASERIN HYDROCHLORIDE's compliance with LORCASERIN HYDROCHLORIDE specifications and serves as a tool for batch-level quality control.
LORCASERIN HYDROCHLORIDE CoA mostly includes findings from lab analyses of a specific batch. For each LORCASERIN 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.
LORCASERIN HYDROCHLORIDE may be tested according to a variety of international standards, such as European Pharmacopoeia (LORCASERIN HYDROCHLORIDE EP), LORCASERIN HYDROCHLORIDE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (LORCASERIN HYDROCHLORIDE USP).
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