01 1DEAFARMA
02 1Glenmark Life Sciences
03 1Glenmark Pharmaceuticals
04 1Hetero Drugs
05 1Maithri Drugs
06 1Synergene Active Ingredients Pvt Ltd
01 5India
02 1Italy
01 2Active
02 4Blank
01 6Blank
01 6Blank
01 1WC-0310
02 1WC-0407
03 4Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31454
Submission : 2017-02-22
Status : Active
Type : II
Date of Issue : 2020-09-09
Valid Till : 2023-06-28
Written Confirmation Number : WC-0407
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-04-08
Pay. Date : 2016-03-23
DMF Number : 30272
Submission : 2016-03-23
Status : Active
Type : II
Date of Issue : 2023-12-28
Valid Till : 2026-12-28
Written Confirmation Number : WC-0310
Address of the Firm :
NDC Package Code : 66039-923
Start Marketing Date : 2016-03-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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