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ABOUT THIS PAGE
A Polaprezinc manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polaprezinc, including repackagers and relabelers. The FDA regulates Polaprezinc manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polaprezinc 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 Polaprezinc manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Polaprezinc supplier is an individual or a company that provides Polaprezinc active pharmaceutical ingredient (API) or Polaprezinc finished formulations upon request. The Polaprezinc suppliers may include Polaprezinc API manufacturers, exporters, distributors and traders.
click here to find a list of Polaprezinc suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Polaprezinc DMF (Drug Master File) is a document detailing the whole manufacturing process of Polaprezinc active pharmaceutical ingredient (API) in detail. Different forms of Polaprezinc DMFs exist exist since differing nations have different regulations, such as Polaprezinc USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Polaprezinc DMF submitted to regulatory agencies in the US is known as a USDMF. Polaprezinc USDMF includes data on Polaprezinc's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polaprezinc USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Polaprezinc 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 Polaprezinc Drug Master File in Japan (Polaprezinc JDMF) empowers Polaprezinc 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 Polaprezinc JDMF during the approval evaluation for pharmaceutical products. At the time of Polaprezinc 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 Polaprezinc 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 Polaprezinc Drug Master File in Korea (Polaprezinc KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Polaprezinc. The MFDS reviews the Polaprezinc KDMF as part of the drug registration process and uses the information provided in the Polaprezinc KDMF to evaluate the safety and efficacy of the drug.
After submitting a Polaprezinc 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 Polaprezinc API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Polaprezinc suppliers with KDMF on PharmaCompass.
Polaprezinc 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 Polaprezinc 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 Polaprezinc GMP manufacturer or Polaprezinc GMP API supplier for your needs.
A Polaprezinc CoA (Certificate of Analysis) is a formal document that attests to Polaprezinc's compliance with Polaprezinc specifications and serves as a tool for batch-level quality control.
Polaprezinc CoA mostly includes findings from lab analyses of a specific batch. For each Polaprezinc 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.
Polaprezinc may be tested according to a variety of international standards, such as European Pharmacopoeia (Polaprezinc EP), Polaprezinc JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Polaprezinc USP).
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