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USDMF
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SPI Pharma
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ABOUT THIS PAGE
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PharmaCompass offers a list of Aceclofenac 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 Aceclofenac manufacturer or Aceclofenac supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aceclofenac manufacturer or Aceclofenac supplier.
PharmaCompass also assists you with knowing the Aceclofenac API Price utilized in the formulation of products. Aceclofenac API Price is not always fixed or binding as the Aceclofenac Price is obtained through a variety of data sources. The Aceclofenac Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Airtal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Airtal, including repackagers and relabelers. The FDA regulates Airtal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Airtal 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 Airtal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Airtal supplier is an individual or a company that provides Airtal active pharmaceutical ingredient (API) or Airtal finished formulations upon request. The Airtal suppliers may include Airtal API manufacturers, exporters, distributors and traders.
click here to find a list of Airtal suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Airtal DMF (Drug Master File) is a document detailing the whole manufacturing process of Airtal active pharmaceutical ingredient (API) in detail. Different forms of Airtal DMFs exist exist since differing nations have different regulations, such as Airtal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Airtal DMF submitted to regulatory agencies in the US is known as a USDMF. Airtal USDMF includes data on Airtal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Airtal USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Airtal suppliers with USDMF 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 Airtal Drug Master File in Korea (Airtal KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Airtal. The MFDS reviews the Airtal KDMF as part of the drug registration process and uses the information provided in the Airtal KDMF to evaluate the safety and efficacy of the drug.
After submitting a Airtal 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 Airtal API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Airtal suppliers with KDMF on PharmaCompass.
A Airtal CEP of the European Pharmacopoeia monograph is often referred to as a Airtal Certificate of Suitability (COS). The purpose of a Airtal CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Airtal EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Airtal to their clients by showing that a Airtal CEP has been issued for it. The manufacturer submits a Airtal CEP (COS) as part of the market authorization procedure, and it takes on the role of a Airtal CEP holder for the record. Additionally, the data presented in the Airtal CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Airtal DMF.
A Airtal CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Airtal 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 Airtal suppliers with CEP (COS) on PharmaCompass.
A Airtal written confirmation (Airtal WC) is an official document issued by a regulatory agency to a Airtal manufacturer, verifying that the manufacturing facility of a Airtal active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Airtal APIs or Airtal finished pharmaceutical products to another nation, regulatory agencies frequently require a Airtal WC (written confirmation) as part of the regulatory process.
click here to find a list of Airtal suppliers with Written Confirmation (WC) on PharmaCompass.
Airtal 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 Airtal 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 Airtal GMP manufacturer or Airtal GMP API supplier for your needs.
A Airtal CoA (Certificate of Analysis) is a formal document that attests to Airtal's compliance with Airtal specifications and serves as a tool for batch-level quality control.
Airtal CoA mostly includes findings from lab analyses of a specific batch. For each Airtal 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.
Airtal may be tested according to a variety of international standards, such as European Pharmacopoeia (Airtal EP), Airtal JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Airtal USP).
