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API SUPPLIERS
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USDMF
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Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Nitrendipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitrendipine, including repackagers and relabelers. The FDA regulates Nitrendipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitrendipine 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 Nitrendipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nitrendipine supplier is an individual or a company that provides Nitrendipine active pharmaceutical ingredient (API) or Nitrendipine finished formulations upon request. The Nitrendipine suppliers may include Nitrendipine API manufacturers, exporters, distributors and traders.
click here to find a list of Nitrendipine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nitrendipine DMF (Drug Master File) is a document detailing the whole manufacturing process of Nitrendipine active pharmaceutical ingredient (API) in detail. Different forms of Nitrendipine DMFs exist exist since differing nations have different regulations, such as Nitrendipine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nitrendipine DMF submitted to regulatory agencies in the US is known as a USDMF. Nitrendipine USDMF includes data on Nitrendipine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nitrendipine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nitrendipine 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 Nitrendipine Drug Master File in Japan (Nitrendipine JDMF) empowers Nitrendipine 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 Nitrendipine JDMF during the approval evaluation for pharmaceutical products. At the time of Nitrendipine 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 Nitrendipine suppliers with JDMF on PharmaCompass.
A Nitrendipine CEP of the European Pharmacopoeia monograph is often referred to as a Nitrendipine Certificate of Suitability (COS). The purpose of a Nitrendipine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nitrendipine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nitrendipine to their clients by showing that a Nitrendipine CEP has been issued for it. The manufacturer submits a Nitrendipine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nitrendipine CEP holder for the record. Additionally, the data presented in the Nitrendipine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nitrendipine DMF.
A Nitrendipine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nitrendipine 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 Nitrendipine suppliers with CEP (COS) on PharmaCompass.
Nitrendipine 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 Nitrendipine 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 Nitrendipine GMP manufacturer or Nitrendipine GMP API supplier for your needs.
A Nitrendipine CoA (Certificate of Analysis) is a formal document that attests to Nitrendipine's compliance with Nitrendipine specifications and serves as a tool for batch-level quality control.
Nitrendipine CoA mostly includes findings from lab analyses of a specific batch. For each Nitrendipine 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.
Nitrendipine may be tested according to a variety of international standards, such as European Pharmacopoeia (Nitrendipine EP), Nitrendipine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nitrendipine USP).
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