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API SUPPLIERS
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USDMF
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API Imports and Exports
FDF Dossiers
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Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Locetar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Locetar, including repackagers and relabelers. The FDA regulates Locetar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Locetar 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 Locetar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Locetar supplier is an individual or a company that provides Locetar active pharmaceutical ingredient (API) or Locetar finished formulations upon request. The Locetar suppliers may include Locetar API manufacturers, exporters, distributors and traders.
click here to find a list of Locetar suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Locetar DMF (Drug Master File) is a document detailing the whole manufacturing process of Locetar active pharmaceutical ingredient (API) in detail. Different forms of Locetar DMFs exist exist since differing nations have different regulations, such as Locetar USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Locetar DMF submitted to regulatory agencies in the US is known as a USDMF. Locetar USDMF includes data on Locetar's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Locetar USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Locetar suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Locetar Drug Master File in Japan (Locetar JDMF) empowers Locetar API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Locetar JDMF during the approval evaluation for pharmaceutical products. At the time of Locetar JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Locetar suppliers with JDMF 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 Locetar Drug Master File in Korea (Locetar KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Locetar. The MFDS reviews the Locetar KDMF as part of the drug registration process and uses the information provided in the Locetar KDMF to evaluate the safety and efficacy of the drug.
After submitting a Locetar 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 Locetar API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Locetar suppliers with KDMF on PharmaCompass.
A Locetar CEP of the European Pharmacopoeia monograph is often referred to as a Locetar Certificate of Suitability (COS). The purpose of a Locetar CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Locetar EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Locetar to their clients by showing that a Locetar CEP has been issued for it. The manufacturer submits a Locetar CEP (COS) as part of the market authorization procedure, and it takes on the role of a Locetar CEP holder for the record. Additionally, the data presented in the Locetar CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Locetar DMF.
A Locetar CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Locetar CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Locetar suppliers with CEP (COS) on PharmaCompass.
A Locetar written confirmation (Locetar WC) is an official document issued by a regulatory agency to a Locetar manufacturer, verifying that the manufacturing facility of a Locetar active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Locetar APIs or Locetar finished pharmaceutical products to another nation, regulatory agencies frequently require a Locetar WC (written confirmation) as part of the regulatory process.
click here to find a list of Locetar suppliers with Written Confirmation (WC) on PharmaCompass.
Locetar 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 Locetar 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 Locetar GMP manufacturer or Locetar GMP API supplier for your needs.
A Locetar CoA (Certificate of Analysis) is a formal document that attests to Locetar's compliance with Locetar specifications and serves as a tool for batch-level quality control.
Locetar CoA mostly includes findings from lab analyses of a specific batch. For each Locetar 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.
Locetar may be tested according to a variety of international standards, such as European Pharmacopoeia (Locetar EP), Locetar JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Locetar USP).
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