Synopsis
0
USDMF
0
CEP/COS
0
EU WC
0
NDC API
0
VMF
0
FDF
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
0
News #PharmaBuzz
INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
DATA COMPILATION #PharmaFlow
Global Sales Information
Market Place
ABOUT THIS PAGE
A Azelnidipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azelnidipine, including repackagers and relabelers. The FDA regulates Azelnidipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azelnidipine 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 Azelnidipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Azelnidipine supplier is an individual or a company that provides Azelnidipine active pharmaceutical ingredient (API) or Azelnidipine finished formulations upon request. The Azelnidipine suppliers may include Azelnidipine API manufacturers, exporters, distributors and traders.
click here to find a list of Azelnidipine 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 Azelnidipine Drug Master File in Japan (Azelnidipine JDMF) empowers Azelnidipine 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 Azelnidipine JDMF during the approval evaluation for pharmaceutical products. At the time of Azelnidipine 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 Azelnidipine 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 Azelnidipine Drug Master File in Korea (Azelnidipine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Azelnidipine. The MFDS reviews the Azelnidipine KDMF as part of the drug registration process and uses the information provided in the Azelnidipine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Azelnidipine 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 Azelnidipine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Azelnidipine suppliers with KDMF on PharmaCompass.
Azelnidipine 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 Azelnidipine 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 Azelnidipine GMP manufacturer or Azelnidipine GMP API supplier for your needs.
A Azelnidipine CoA (Certificate of Analysis) is a formal document that attests to Azelnidipine's compliance with Azelnidipine specifications and serves as a tool for batch-level quality control.
Azelnidipine CoA mostly includes findings from lab analyses of a specific batch. For each Azelnidipine 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.
Azelnidipine may be tested according to a variety of international standards, such as European Pharmacopoeia (Azelnidipine EP), Azelnidipine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Azelnidipine USP).
LOOKING FOR A SUPPLIER?
