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PharmaCompass offers a list of Promethazine 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 Promethazine manufacturer or Promethazine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Promethazine manufacturer or Promethazine supplier.
PharmaCompass also assists you with knowing the Promethazine API Price utilized in the formulation of products. Promethazine API Price is not always fixed or binding as the Promethazine Price is obtained through a variety of data sources. The Promethazine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Promethazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Promethazine, including repackagers and relabelers. The FDA regulates Promethazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Promethazine 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 Promethazine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Promethazine supplier is an individual or a company that provides Promethazine active pharmaceutical ingredient (API) or Promethazine finished formulations upon request. The Promethazine suppliers may include Promethazine API manufacturers, exporters, distributors and traders.
click here to find a list of Promethazine 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 Promethazine Drug Master File in Japan (Promethazine JDMF) empowers Promethazine 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 Promethazine JDMF during the approval evaluation for pharmaceutical products. At the time of Promethazine 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 Promethazine suppliers with JDMF on PharmaCompass.
Promethazine 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 Promethazine 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 Promethazine GMP manufacturer or Promethazine GMP API supplier for your needs.
A Promethazine CoA (Certificate of Analysis) is a formal document that attests to Promethazine's compliance with Promethazine specifications and serves as a tool for batch-level quality control.
Promethazine CoA mostly includes findings from lab analyses of a specific batch. For each Promethazine 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.
Promethazine may be tested according to a variety of international standards, such as European Pharmacopoeia (Promethazine EP), Promethazine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Promethazine USP).