Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1Centrient Pharmaceuticals
01 1CEFADROXIL MONOHYDRATE USP (PURIDROX ®)
01 1Netherlands
01 1Active
01 1Complete
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-22
Pay. Date : 2013-01-11
DMF Number : 13749
Submission : 1998-09-01
Status : Active
Type : II
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PharmaCompass also assists you with knowing the Cefadroxil Monohydrate API Price utilized in the formulation of products. Cefadroxil Monohydrate API Price is not always fixed or binding as the Cefadroxil Monohydrate Price is obtained through a variety of data sources. The Cefadroxil Monohydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cefadroxil Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefadroxil Monohydrate, including repackagers and relabelers. The FDA regulates Cefadroxil Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefadroxil Monohydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Cefadroxil Monohydrate supplier is an individual or a company that provides Cefadroxil Monohydrate active pharmaceutical ingredient (API) or Cefadroxil Monohydrate finished formulations upon request. The Cefadroxil Monohydrate suppliers may include Cefadroxil Monohydrate API manufacturers, exporters, distributors and traders.
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A Cefadroxil Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefadroxil Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Cefadroxil Monohydrate DMFs exist exist since differing nations have different regulations, such as Cefadroxil Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefadroxil Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Cefadroxil Monohydrate USDMF includes data on Cefadroxil Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefadroxil Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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