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API SUPPLIERS
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USDMF
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of experience in formulation development, manufacturing, and commercialization. Its portfoli...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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DOSAGE - TABLET;ORAL - 25MG **Federal Registe...DOSAGE - TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20142
DOSAGE - TABLET;ORAL - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20142
DOSAGE - CAPSULE;ORAL - 25MG
USFDA APPLICATION NUMBER - 22202
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ABOUT THIS PAGE
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PharmaCompass offers a list of Diclofenac Potassium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Diclofenac Potassium manufacturer or Diclofenac Potassium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Diclofenac Potassium manufacturer or Diclofenac Potassium supplier.
A Voltfast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Voltfast, including repackagers and relabelers. The FDA regulates Voltfast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Voltfast 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 Voltfast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Voltfast supplier is an individual or a company that provides Voltfast active pharmaceutical ingredient (API) or Voltfast finished formulations upon request. The Voltfast suppliers may include Voltfast API manufacturers, exporters, distributors and traders.
click here to find a list of Voltfast suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Voltfast DMF (Drug Master File) is a document detailing the whole manufacturing process of Voltfast active pharmaceutical ingredient (API) in detail. Different forms of Voltfast DMFs exist exist since differing nations have different regulations, such as Voltfast USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Voltfast DMF submitted to regulatory agencies in the US is known as a USDMF. Voltfast USDMF includes data on Voltfast's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Voltfast USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Voltfast 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 Voltfast Drug Master File in Korea (Voltfast KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Voltfast. The MFDS reviews the Voltfast KDMF as part of the drug registration process and uses the information provided in the Voltfast KDMF to evaluate the safety and efficacy of the drug.
After submitting a Voltfast 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 Voltfast API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Voltfast suppliers with KDMF on PharmaCompass.
A Voltfast CEP of the European Pharmacopoeia monograph is often referred to as a Voltfast Certificate of Suitability (COS). The purpose of a Voltfast CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Voltfast EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Voltfast to their clients by showing that a Voltfast CEP has been issued for it. The manufacturer submits a Voltfast CEP (COS) as part of the market authorization procedure, and it takes on the role of a Voltfast CEP holder for the record. Additionally, the data presented in the Voltfast CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Voltfast DMF.
A Voltfast CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Voltfast 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 Voltfast suppliers with CEP (COS) on PharmaCompass.
A Voltfast written confirmation (Voltfast WC) is an official document issued by a regulatory agency to a Voltfast manufacturer, verifying that the manufacturing facility of a Voltfast active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Voltfast APIs or Voltfast finished pharmaceutical products to another nation, regulatory agencies frequently require a Voltfast WC (written confirmation) as part of the regulatory process.
click here to find a list of Voltfast 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 Voltfast as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Voltfast 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 Voltfast 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 Voltfast and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Voltfast NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Voltfast suppliers with NDC on PharmaCompass.
Voltfast 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 Voltfast GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Voltfast GMP manufacturer or Voltfast GMP API supplier for your needs.
A Voltfast CoA (Certificate of Analysis) is a formal document that attests to Voltfast's compliance with Voltfast specifications and serves as a tool for batch-level quality control.
Voltfast CoA mostly includes findings from lab analyses of a specific batch. For each Voltfast 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.
Voltfast may be tested according to a variety of international standards, such as European Pharmacopoeia (Voltfast EP), Voltfast JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Voltfast USP).
