01 2Johnson & Johnson Innovative Medicine
02 2Vasudha Pharma Chem
01 2India
02 2U.S.A
01 1Active
02 3Blank
01 2Withdrawn by Holder
02 2Blank
01 4Blank
01 2WC-0070
02 2Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31230
Submission : 2017-01-11
Status : Active
Type : II
Date of Issue : 2022-06-14
Valid Till : 2025-07-04
Written Confirmation Number : WC-0070
Address of the Firm :
NDC Package Code : 66577-023
Start Marketing Date : 1999-11-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Certificate Number : R1-CEP 1997-061 - Rev 02
Issue Date : 2008-06-20
Type : Chemical
Substance Number : 995
Status : Withdrawn by Holder
Certificate Number : R1-CEP 1996-100 - Rev 02
Issue Date : 2007-03-07
Type : Chemical
Substance Number : 995
Status : Withdrawn by Holder
Date of Issue : 2022-06-14
Valid Till : 2025-07-04
Written Confirmation Number : WC-0070
Address of the Firm :
NDC Package Code : 66577-023
Start Marketing Date : 1999-11-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
A Cisapride Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cisapride Monohydrate, including repackagers and relabelers. The FDA regulates Cisapride Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cisapride 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.
click here to find a list of Cisapride Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cisapride Monohydrate supplier is an individual or a company that provides Cisapride Monohydrate active pharmaceutical ingredient (API) or Cisapride Monohydrate finished formulations upon request. The Cisapride Monohydrate suppliers may include Cisapride Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Cisapride Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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