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