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PharmaCompass offers a list of Zinc Acetate 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 Zinc Acetate manufacturer or Zinc Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Zinc Acetate manufacturer or Zinc Acetate supplier.
PharmaCompass also assists you with knowing the Zinc Acetate API Price utilized in the formulation of products. Zinc Acetate API Price is not always fixed or binding as the Zinc Acetate Price is obtained through a variety of data sources. The Zinc Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Zinc Acetate Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zinc Acetate Dihydrate, including repackagers and relabelers. The FDA regulates Zinc Acetate Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zinc Acetate Dihydrate 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 Acetate Dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zinc Acetate Dihydrate supplier is an individual or a company that provides Zinc Acetate Dihydrate active pharmaceutical ingredient (API) or Zinc Acetate Dihydrate finished formulations upon request. The Zinc Acetate Dihydrate suppliers may include Zinc Acetate Dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Zinc Acetate Dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zinc Acetate Dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Zinc Acetate Dihydrate active pharmaceutical ingredient (API) in detail. Different forms of Zinc Acetate Dihydrate DMFs exist exist since differing nations have different regulations, such as Zinc Acetate Dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zinc Acetate Dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Zinc Acetate Dihydrate USDMF includes data on Zinc Acetate Dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zinc Acetate Dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zinc Acetate Dihydrate 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 Acetate Dihydrate Drug Master File in Japan (Zinc Acetate Dihydrate JDMF) empowers Zinc Acetate Dihydrate 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 Acetate Dihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Zinc Acetate Dihydrate 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 Acetate Dihydrate suppliers with JDMF on PharmaCompass.
A Zinc Acetate Dihydrate CEP of the European Pharmacopoeia monograph is often referred to as a Zinc Acetate Dihydrate Certificate of Suitability (COS). The purpose of a Zinc Acetate Dihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Zinc Acetate Dihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Zinc Acetate Dihydrate to their clients by showing that a Zinc Acetate Dihydrate CEP has been issued for it. The manufacturer submits a Zinc Acetate Dihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Zinc Acetate Dihydrate CEP holder for the record. Additionally, the data presented in the Zinc Acetate Dihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Zinc Acetate Dihydrate DMF.
A Zinc Acetate Dihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zinc Acetate Dihydrate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Zinc Acetate Dihydrate suppliers with CEP (COS) on PharmaCompass.
A Zinc Acetate Dihydrate written confirmation (Zinc Acetate Dihydrate WC) is an official document issued by a regulatory agency to a Zinc Acetate Dihydrate manufacturer, verifying that the manufacturing facility of a Zinc Acetate Dihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zinc Acetate Dihydrate APIs or Zinc Acetate Dihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Zinc Acetate Dihydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Zinc Acetate Dihydrate suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Zinc Acetate Dihydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zinc Acetate Dihydrate API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Zinc Acetate Dihydrate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Zinc Acetate Dihydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zinc Acetate Dihydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zinc Acetate Dihydrate suppliers with NDC on PharmaCompass.
Zinc Acetate Dihydrate 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 Acetate Dihydrate 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 Acetate Dihydrate GMP manufacturer or Zinc Acetate Dihydrate GMP API supplier for your needs.
A Zinc Acetate Dihydrate CoA (Certificate of Analysis) is a formal document that attests to Zinc Acetate Dihydrate's compliance with Zinc Acetate Dihydrate specifications and serves as a tool for batch-level quality control.
Zinc Acetate Dihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Zinc Acetate Dihydrate 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 Acetate Dihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Zinc Acetate Dihydrate EP), Zinc Acetate Dihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zinc Acetate Dihydrate USP).