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ABOUT THIS PAGE
A Papaverine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Papaverine Hydrochloride, including repackagers and relabelers. The FDA regulates Papaverine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Papaverine 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 Papaverine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Papaverine Hydrochloride supplier is an individual or a company that provides Papaverine Hydrochloride active pharmaceutical ingredient (API) or Papaverine Hydrochloride finished formulations upon request. The Papaverine Hydrochloride suppliers may include Papaverine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Papaverine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Papaverine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Papaverine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Papaverine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Papaverine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Papaverine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Papaverine Hydrochloride USDMF includes data on Papaverine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Papaverine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Papaverine 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 Papaverine Hydrochloride Drug Master File in Japan (Papaverine Hydrochloride JDMF) empowers Papaverine 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 Papaverine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Papaverine 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 Papaverine Hydrochloride suppliers with JDMF on PharmaCompass.
A Papaverine Hydrochloride written confirmation (Papaverine Hydrochloride WC) is an official document issued by a regulatory agency to a Papaverine Hydrochloride manufacturer, verifying that the manufacturing facility of a Papaverine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Papaverine Hydrochloride APIs or Papaverine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Papaverine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Papaverine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Papaverine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Papaverine Hydrochloride API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Papaverine Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Papaverine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Papaverine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Papaverine Hydrochloride suppliers with NDC on PharmaCompass.
Papaverine 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 Papaverine 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 Papaverine Hydrochloride GMP manufacturer or Papaverine Hydrochloride GMP API supplier for your needs.
A Papaverine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Papaverine Hydrochloride's compliance with Papaverine Hydrochloride specifications and serves as a tool for batch-level quality control.
Papaverine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Papaverine 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.
Papaverine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Papaverine Hydrochloride EP), Papaverine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Papaverine Hydrochloride USP).
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