Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1ACS DOBFAR SPA
03 2Aurobindo Pharma Limited
04 1Eli Lilly
05 1Fresenius Kabi AB Brunna
06 1GSK
07 1Nectar Lifesciences
08 1Orchid Pharma
09 2Qilu Antibiotics Pharmaceutical Co., Ltd.
10 1Sterile India Pvt. Ltd
11 1Wockhardt
12 1Zhuhai United Laboratories Co ., Ltd.
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18722
Submission : 2005-09-01
Status :
Type : II
A Cefuroxime Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefuroxime Sodium, including repackagers and relabelers. The FDA regulates Cefuroxime Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefuroxime Sodium 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 Cefuroxime Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefuroxime Sodium supplier is an individual or a company that provides Cefuroxime Sodium active pharmaceutical ingredient (API) or Cefuroxime Sodium finished formulations upon request. The Cefuroxime Sodium suppliers may include Cefuroxime Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Cefuroxime Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cefuroxime Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefuroxime Sodium active pharmaceutical ingredient (API) in detail. Different forms of Cefuroxime Sodium DMFs exist exist since differing nations have different regulations, such as Cefuroxime Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefuroxime Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Cefuroxime Sodium USDMF includes data on Cefuroxime Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefuroxime Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefuroxime Sodium suppliers with USDMF on PharmaCompass.
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