01 1Choongwae Pharma Corporation
02 1RANBAXY LABORATORIES LIMITED
03 1Savior Lifetec Corporation
01 2CILASTATIN ACID
02 1CILASTATIN SODIUM STERILE
01 1India
02 1Taiwan
03 1Blank
01 2Active
02 1Inactive
01 1Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23181
Submission : 2009-10-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20046
Submission : 2006-12-16
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-06
Pay. Date : 2013-05-22
DMF Number : 19938
Submission : 2006-10-30
Status : Active
Type : II
A Cilastatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cilastatin, including repackagers and relabelers. The FDA regulates Cilastatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cilastatin 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 Cilastatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cilastatin supplier is an individual or a company that provides Cilastatin active pharmaceutical ingredient (API) or Cilastatin finished formulations upon request. The Cilastatin suppliers may include Cilastatin API manufacturers, exporters, distributors and traders.
click here to find a list of Cilastatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cilastatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Cilastatin active pharmaceutical ingredient (API) in detail. Different forms of Cilastatin DMFs exist exist since differing nations have different regulations, such as Cilastatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cilastatin DMF submitted to regulatory agencies in the US is known as a USDMF. Cilastatin USDMF includes data on Cilastatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cilastatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cilastatin suppliers with USDMF on PharmaCompass.
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