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ABOUT THIS PAGE
A Temocapril Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Temocapril Hydrochloride, including repackagers and relabelers. The FDA regulates Temocapril Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Temocapril Hydrochloride 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 Temocapril Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Temocapril Hydrochloride supplier is an individual or a company that provides Temocapril Hydrochloride active pharmaceutical ingredient (API) or Temocapril Hydrochloride finished formulations upon request. The Temocapril Hydrochloride suppliers may include Temocapril Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Temocapril Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Temocapril Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Temocapril Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Temocapril Hydrochloride DMFs exist exist since differing nations have different regulations, such as Temocapril Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Temocapril Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Temocapril Hydrochloride USDMF includes data on Temocapril Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Temocapril Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Temocapril Hydrochloride 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 Temocapril Hydrochloride Drug Master File in Japan (Temocapril Hydrochloride JDMF) empowers Temocapril Hydrochloride 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 Temocapril Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Temocapril Hydrochloride 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 Temocapril Hydrochloride suppliers with JDMF on PharmaCompass.
Temocapril Hydrochloride 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 Temocapril Hydrochloride 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 Temocapril Hydrochloride GMP manufacturer or Temocapril Hydrochloride GMP API supplier for your needs.
A Temocapril Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Temocapril Hydrochloride's compliance with Temocapril Hydrochloride specifications and serves as a tool for batch-level quality control.
Temocapril Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Temocapril Hydrochloride 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.
Temocapril Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Temocapril Hydrochloride EP), Temocapril Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Temocapril Hydrochloride USP).
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