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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **...DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50564
DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **...DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50564
DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 3...DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML
USFDA APPLICATION NUMBER - 50575
DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 6...DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML
USFDA APPLICATION NUMBER - 50575
DOSAGE - TABLET;ORAL - 875MG;EQ 125MG BASE
USFDA APPLICATION NUMBER - 50720
DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 2...DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML
USFDA APPLICATION NUMBER - 50725
DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 5...DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML
USFDA APPLICATION NUMBER - 50725
DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 4...DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML
USFDA APPLICATION NUMBER - 50755
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE
USFDA APPLICATION NUMBER - 50785
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Clavulanic Acid 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 Clavulanic Acid manufacturer or Clavulanic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Clavulanic Acid manufacturer or Clavulanic Acid supplier.
A Potassium Clavulanate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Clavulanate, including repackagers and relabelers. The FDA regulates Potassium Clavulanate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium Clavulanate 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 Potassium Clavulanate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Potassium Clavulanate supplier is an individual or a company that provides Potassium Clavulanate active pharmaceutical ingredient (API) or Potassium Clavulanate finished formulations upon request. The Potassium Clavulanate suppliers may include Potassium Clavulanate API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Clavulanate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Potassium Clavulanate DMF (Drug Master File) is a document detailing the whole manufacturing process of Potassium Clavulanate active pharmaceutical ingredient (API) in detail. Different forms of Potassium Clavulanate DMFs exist exist since differing nations have different regulations, such as Potassium Clavulanate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Potassium Clavulanate DMF submitted to regulatory agencies in the US is known as a USDMF. Potassium Clavulanate USDMF includes data on Potassium Clavulanate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Potassium Clavulanate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Potassium Clavulanate 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 Potassium Clavulanate Drug Master File in Korea (Potassium Clavulanate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Potassium Clavulanate. The MFDS reviews the Potassium Clavulanate KDMF as part of the drug registration process and uses the information provided in the Potassium Clavulanate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Potassium Clavulanate 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 Potassium Clavulanate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Potassium Clavulanate suppliers with KDMF on PharmaCompass.
A Potassium Clavulanate CEP of the European Pharmacopoeia monograph is often referred to as a Potassium Clavulanate Certificate of Suitability (COS). The purpose of a Potassium Clavulanate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Potassium Clavulanate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Potassium Clavulanate to their clients by showing that a Potassium Clavulanate CEP has been issued for it. The manufacturer submits a Potassium Clavulanate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Potassium Clavulanate CEP holder for the record. Additionally, the data presented in the Potassium Clavulanate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Potassium Clavulanate DMF.
A Potassium Clavulanate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Potassium Clavulanate 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 Potassium Clavulanate 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 Potassium Clavulanate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Potassium Clavulanate 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 Potassium Clavulanate 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 Potassium Clavulanate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Potassium Clavulanate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Potassium Clavulanate suppliers with NDC on PharmaCompass.
Potassium Clavulanate 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 Potassium Clavulanate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Potassium Clavulanate GMP manufacturer or Potassium Clavulanate GMP API supplier for your needs.
A Potassium Clavulanate CoA (Certificate of Analysis) is a formal document that attests to Potassium Clavulanate's compliance with Potassium Clavulanate specifications and serves as a tool for batch-level quality control.
Potassium Clavulanate CoA mostly includes findings from lab analyses of a specific batch. For each Potassium Clavulanate 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.
Potassium Clavulanate may be tested according to a variety of international standards, such as European Pharmacopoeia (Potassium Clavulanate EP), Potassium Clavulanate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Potassium Clavulanate USP).
