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API SUPPLIERS
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
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USDMF
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
A Cefprozil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefprozil, including repackagers and relabelers. The FDA regulates Cefprozil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefprozil 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 Cefprozil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefprozil supplier is an individual or a company that provides Cefprozil active pharmaceutical ingredient (API) or Cefprozil finished formulations upon request. The Cefprozil suppliers may include Cefprozil API manufacturers, exporters, distributors and traders.
click here to find a list of Cefprozil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cefprozil DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefprozil active pharmaceutical ingredient (API) in detail. Different forms of Cefprozil DMFs exist exist since differing nations have different regulations, such as Cefprozil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefprozil DMF submitted to regulatory agencies in the US is known as a USDMF. Cefprozil USDMF includes data on Cefprozil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefprozil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefprozil 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 Cefprozil Drug Master File in Korea (Cefprozil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cefprozil. The MFDS reviews the Cefprozil KDMF as part of the drug registration process and uses the information provided in the Cefprozil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cefprozil 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 Cefprozil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cefprozil suppliers with KDMF on PharmaCompass.
A Cefprozil CEP of the European Pharmacopoeia monograph is often referred to as a Cefprozil Certificate of Suitability (COS). The purpose of a Cefprozil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cefprozil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cefprozil to their clients by showing that a Cefprozil CEP has been issued for it. The manufacturer submits a Cefprozil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cefprozil CEP holder for the record. Additionally, the data presented in the Cefprozil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cefprozil DMF.
A Cefprozil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cefprozil 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 Cefprozil suppliers with CEP (COS) on PharmaCompass.
A Cefprozil written confirmation (Cefprozil WC) is an official document issued by a regulatory agency to a Cefprozil manufacturer, verifying that the manufacturing facility of a Cefprozil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cefprozil APIs or Cefprozil finished pharmaceutical products to another nation, regulatory agencies frequently require a Cefprozil WC (written confirmation) as part of the regulatory process.
click here to find a list of Cefprozil 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 Cefprozil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cefprozil 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 Cefprozil 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 Cefprozil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefprozil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cefprozil suppliers with NDC on PharmaCompass.
Cefprozil 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 Cefprozil 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 Cefprozil GMP manufacturer or Cefprozil GMP API supplier for your needs.
A Cefprozil CoA (Certificate of Analysis) is a formal document that attests to Cefprozil's compliance with Cefprozil specifications and serves as a tool for batch-level quality control.
Cefprozil CoA mostly includes findings from lab analyses of a specific batch. For each Cefprozil 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.
Cefprozil may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefprozil EP), Cefprozil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefprozil USP).
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