01 1ALP Pharm
02 1Alembic Pharmaceuticals Limited
03 1Hetero Drugs
04 1Hunan Huateng Pharmaceutical Co ltd
05 2MSN Laboratories
06 1Sun Pharmaceutical Industries Limited
01 2China
02 5India
01 5Active
02 2Blank
01 7Blank
01 1306MF10032
02 6Blank
01 1WC-0082
02 1WC-0349
03 5Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31218
Submission : 2016-12-12
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-09-02
Pay. Date : 2016-06-10
DMF Number : 30552
Submission : 2016-06-30
Status : Active
Type : II
Registration Number : 306MF10032
Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India
Initial Date of Registration : 2024-02-21
Latest Date of Registration : --
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-13
Pay. Date : 2021-08-11
DMF Number : 36121
Submission : 2021-08-19
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-05
Pay. Date : 2016-05-10
DMF Number : 30218
Submission : 2016-02-05
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0041
Start Marketing Date : 2016-02-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-09-14
Pay. Date : 2016-07-01
DMF Number : 30278
Submission : 2016-02-26
Status : Active
Type : II
NDC Package Code : 54893-0041
Start Marketing Date : 2016-02-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 68554-0161
Start Marketing Date : 2023-09-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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