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PharmaCompass offers a list of Aprindine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Aprindine Hydrochloride manufacturer or Aprindine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aprindine Hydrochloride manufacturer or Aprindine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Aprindine Hydrochloride API Price utilized in the formulation of products. Aprindine Hydrochloride API Price is not always fixed or binding as the Aprindine Hydrochloride Price is obtained through a variety of data sources. The Aprindine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Aprindine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aprindine Hydrochloride, including repackagers and relabelers. The FDA regulates Aprindine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aprindine 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.
A Aprindine Hydrochloride supplier is an individual or a company that provides Aprindine Hydrochloride active pharmaceutical ingredient (API) or Aprindine Hydrochloride finished formulations upon request. The Aprindine Hydrochloride suppliers may include Aprindine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Aprindine 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 Aprindine Hydrochloride Drug Master File in Japan (Aprindine Hydrochloride JDMF) empowers Aprindine 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 Aprindine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Aprindine 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 Aprindine Hydrochloride suppliers with JDMF on PharmaCompass.
A Aprindine Hydrochloride written confirmation (Aprindine Hydrochloride WC) is an official document issued by a regulatory agency to a Aprindine Hydrochloride manufacturer, verifying that the manufacturing facility of a Aprindine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aprindine Hydrochloride APIs or Aprindine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Aprindine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Aprindine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
Aprindine 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 Aprindine 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 Aprindine Hydrochloride GMP manufacturer or Aprindine Hydrochloride GMP API supplier for your needs.
A Aprindine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Aprindine Hydrochloride's compliance with Aprindine Hydrochloride specifications and serves as a tool for batch-level quality control.
Aprindine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Aprindine 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.
Aprindine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Aprindine Hydrochloride EP), Aprindine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aprindine Hydrochloride USP).
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