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