01 1Hospira, Inc.
02 1Savior Lifetec Corporation
01 1IMIPENEM + CILASTATIN SODIUM (STERILE BULK)
02 1IMIPENEM AND CILASTATIN FOR INJECTION STERILE BULK
01 1Taiwan
02 1U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21707
Submission : 2008-07-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21004
Submission : 2007-10-26
Status : Active
Type : II
46
PharmaCompass offers a list of Imipenem And Cilastatin Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Imipenem And Cilastatin Sodium manufacturer or Imipenem And Cilastatin Sodium supplier for your needs.
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A Imipenem And Cilastatin Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Imipenem And Cilastatin Sodium, including repackagers and relabelers. The FDA regulates Imipenem And Cilastatin Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Imipenem And Cilastatin 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.
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A Imipenem And Cilastatin Sodium supplier is an individual or a company that provides Imipenem And Cilastatin Sodium active pharmaceutical ingredient (API) or Imipenem And Cilastatin Sodium finished formulations upon request. The Imipenem And Cilastatin Sodium suppliers may include Imipenem And Cilastatin Sodium API manufacturers, exporters, distributors and traders.
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A Imipenem And Cilastatin Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Imipenem And Cilastatin Sodium active pharmaceutical ingredient (API) in detail. Different forms of Imipenem And Cilastatin Sodium DMFs exist exist since differing nations have different regulations, such as Imipenem And Cilastatin Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Imipenem And Cilastatin Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Imipenem And Cilastatin Sodium USDMF includes data on Imipenem And Cilastatin Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Imipenem And Cilastatin Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
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