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