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ABOUT THIS PAGE
A Propiverine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Propiverine Hydrochloride, including repackagers and relabelers. The FDA regulates Propiverine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Propiverine 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 Propiverine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Propiverine Hydrochloride supplier is an individual or a company that provides Propiverine Hydrochloride active pharmaceutical ingredient (API) or Propiverine Hydrochloride finished formulations upon request. The Propiverine Hydrochloride suppliers may include Propiverine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Propiverine Hydrochloride 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 Propiverine Hydrochloride Drug Master File in Japan (Propiverine Hydrochloride JDMF) empowers Propiverine 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 Propiverine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Propiverine 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 Propiverine Hydrochloride 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 Propiverine Hydrochloride Drug Master File in Korea (Propiverine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Propiverine Hydrochloride. The MFDS reviews the Propiverine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Propiverine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Propiverine Hydrochloride 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 Propiverine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Propiverine Hydrochloride suppliers with KDMF on PharmaCompass.
A Propiverine Hydrochloride written confirmation (Propiverine Hydrochloride WC) is an official document issued by a regulatory agency to a Propiverine Hydrochloride manufacturer, verifying that the manufacturing facility of a Propiverine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Propiverine Hydrochloride APIs or Propiverine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Propiverine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Propiverine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
Propiverine 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 Propiverine 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 Propiverine Hydrochloride GMP manufacturer or Propiverine Hydrochloride GMP API supplier for your needs.
A Propiverine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Propiverine Hydrochloride's compliance with Propiverine Hydrochloride specifications and serves as a tool for batch-level quality control.
Propiverine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Propiverine 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.
Propiverine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Propiverine Hydrochloride EP), Propiverine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Propiverine Hydrochloride USP).
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