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KDMF
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2022-05-04
Registration Number : 20210528-209-J-770(1)
Manufacturer Name : VLG CHEM
Manufacturer Address : 35, avenue Jean Jaures 92390 VILLENEUVE-LA-GARENNE France
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Registrant Name : Bukwang Pharmaceutical Co., Ltd.
Registration Date : 2021-05-28
Registration Number : 20210528-209-J-770
Manufacturer Name : Pcas
Manufacturer Address : 35, avenue Jean Jaures 92390 VILLENEUVE-LA-GARENNE France
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-05-26
Registration Number : 20210526-209-J-999
Manufacturer Name : Olpha AS
Manufacturer Address : Rŭpnĭcu iela 5, Olaine, Olaines novads, LV-2114, Latvija
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ABOUT THIS PAGE
A Mequitazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mequitazine, including repackagers and relabelers. The FDA regulates Mequitazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mequitazine 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 Mequitazine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mequitazine supplier is an individual or a company that provides Mequitazine active pharmaceutical ingredient (API) or Mequitazine finished formulations upon request. The Mequitazine suppliers may include Mequitazine API manufacturers, exporters, distributors and traders.
click here to find a list of Mequitazine 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 Mequitazine Drug Master File in Japan (Mequitazine JDMF) empowers Mequitazine 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 Mequitazine JDMF during the approval evaluation for pharmaceutical products. At the time of Mequitazine 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 Mequitazine 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 Mequitazine Drug Master File in Korea (Mequitazine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mequitazine. The MFDS reviews the Mequitazine KDMF as part of the drug registration process and uses the information provided in the Mequitazine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mequitazine 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 Mequitazine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mequitazine suppliers with KDMF on PharmaCompass.
Mequitazine 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 Mequitazine 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 Mequitazine GMP manufacturer or Mequitazine GMP API supplier for your needs.
A Mequitazine CoA (Certificate of Analysis) is a formal document that attests to Mequitazine's compliance with Mequitazine specifications and serves as a tool for batch-level quality control.
Mequitazine CoA mostly includes findings from lab analyses of a specific batch. For each Mequitazine 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.
Mequitazine may be tested according to a variety of international standards, such as European Pharmacopoeia (Mequitazine EP), Mequitazine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mequitazine USP).
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