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