01 1Hospira, Inc.
02 1Savior Lifetec Corporation
03 1Shandong Anhong Pharmaceutical
01 1IMIPENEM
02 1IMIPENEM + CILASTATIN SODIUM (STERILE BULK)
03 1IMIPENEM AND CILASTATIN FOR INJECTION STERILE BULK
01 1China
02 1Taiwan
03 1U.S.A
01 2Active
02 1Inactive
01 1Complete
02 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
GDUFA
DMF Review : Complete
Rev. Date : 2025-07-15
Pay. Date : 2025-04-24
DMF Number : 41733
Submission : 2025-05-01
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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PharmaCompass also assists you with knowing the Imipenem And Cilastatin Sodium API Price utilized in the formulation of products. Imipenem And Cilastatin Sodium API Price is not always fixed or binding as the Imipenem And Cilastatin Sodium Price is obtained through a variety of data sources. The Imipenem And Cilastatin Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Imipenem-Cilastatin Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Imipenem-Cilastatin Sodium, including repackagers and relabelers. The FDA regulates Imipenem-Cilastatin Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Imipenem-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-Cilastatin Sodium supplier is an individual or a company that provides Imipenem-Cilastatin Sodium active pharmaceutical ingredient (API) or Imipenem-Cilastatin Sodium finished formulations upon request. The Imipenem-Cilastatin Sodium suppliers may include Imipenem-Cilastatin Sodium API manufacturers, exporters, distributors and traders.
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A Imipenem-Cilastatin Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Imipenem-Cilastatin Sodium active pharmaceutical ingredient (API) in detail. Different forms of Imipenem-Cilastatin Sodium DMFs exist exist since differing nations have different regulations, such as Imipenem-Cilastatin Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Imipenem-Cilastatin Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Imipenem-Cilastatin Sodium USDMF includes data on Imipenem-Cilastatin Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Imipenem-Cilastatin Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
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