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ABOUT THIS PAGE
A Lafutidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lafutidine, including repackagers and relabelers. The FDA regulates Lafutidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lafutidine 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 Lafutidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lafutidine supplier is an individual or a company that provides Lafutidine active pharmaceutical ingredient (API) or Lafutidine finished formulations upon request. The Lafutidine suppliers may include Lafutidine API manufacturers, exporters, distributors and traders.
click here to find a list of Lafutidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Lafutidine Drug Master File in Japan (Lafutidine JDMF) empowers Lafutidine 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 Lafutidine JDMF during the approval evaluation for pharmaceutical products. At the time of Lafutidine 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 Lafutidine 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 Lafutidine Drug Master File in Korea (Lafutidine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lafutidine. The MFDS reviews the Lafutidine KDMF as part of the drug registration process and uses the information provided in the Lafutidine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lafutidine 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 Lafutidine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lafutidine suppliers with KDMF on PharmaCompass.
Lafutidine 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 Lafutidine 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 Lafutidine GMP manufacturer or Lafutidine GMP API supplier for your needs.
A Lafutidine CoA (Certificate of Analysis) is a formal document that attests to Lafutidine's compliance with Lafutidine specifications and serves as a tool for batch-level quality control.
Lafutidine CoA mostly includes findings from lab analyses of a specific batch. For each Lafutidine 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.
Lafutidine may be tested according to a variety of international standards, such as European Pharmacopoeia (Lafutidine EP), Lafutidine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lafutidine USP).
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