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ABOUT THIS PAGE
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PharmaCompass offers a list of Polaprezinc 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 Polaprezinc manufacturer or Polaprezinc supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Polaprezinc manufacturer or Polaprezinc supplier.
PharmaCompass also assists you with knowing the Polaprezinc API Price utilized in the formulation of products. Polaprezinc API Price is not always fixed or binding as the Polaprezinc Price is obtained through a variety of data sources. The Polaprezinc Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Promac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Promac, including repackagers and relabelers. The FDA regulates Promac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Promac 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 Promac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Promac supplier is an individual or a company that provides Promac active pharmaceutical ingredient (API) or Promac finished formulations upon request. The Promac suppliers may include Promac API manufacturers, exporters, distributors and traders.
click here to find a list of Promac suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Promac DMF (Drug Master File) is a document detailing the whole manufacturing process of Promac active pharmaceutical ingredient (API) in detail. Different forms of Promac DMFs exist exist since differing nations have different regulations, such as Promac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Promac DMF submitted to regulatory agencies in the US is known as a USDMF. Promac USDMF includes data on Promac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Promac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Promac 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 Promac Drug Master File in Japan (Promac JDMF) empowers Promac 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 Promac JDMF during the approval evaluation for pharmaceutical products. At the time of Promac 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 Promac 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 Promac Drug Master File in Korea (Promac KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Promac. The MFDS reviews the Promac KDMF as part of the drug registration process and uses the information provided in the Promac KDMF to evaluate the safety and efficacy of the drug.
After submitting a Promac 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 Promac API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Promac suppliers with KDMF on PharmaCompass.
Promac 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 Promac 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 Promac GMP manufacturer or Promac GMP API supplier for your needs.
A Promac CoA (Certificate of Analysis) is a formal document that attests to Promac's compliance with Promac specifications and serves as a tool for batch-level quality control.
Promac CoA mostly includes findings from lab analyses of a specific batch. For each Promac 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.
Promac may be tested according to a variety of international standards, such as European Pharmacopoeia (Promac EP), Promac JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Promac USP).
