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01 1Acetic Anhydride
02 1Acetyl Chloride
03 1Allopurinol
04 1Allopurinol Sodium
05 1Apixaban
06 1Chloroacetic Acid
07 1Choline Fenofibrate
08 1Clopidogrel
09 1Clopidogrel Besylate
10 1Edoxaban Tosylate
11 1Ethyl Acetate
12 1Fenofibrate
13 1Gabapentin
14 2Ibuprofen
15 1Ibuprofen Lysinate
16 1Ibuprofen Piconol
17 1Ibuprofen Sodium
18 1Iso Butyl Benzene
19 2Lamotrigine
20 1Levetiracetam
21 1Losartan Potassium
22 1Mesalazine
23 2Metformin
24 1Minoxidil
25 1Pantoprazole Magnesium
26 2Pantoprazole Sodium
27 1Paracetamol
28 1Quetiapine Hemifumarate
29 1Sacubitril Sodium
30 1Sitagliptin Phosphate
31 1Valsartan
32 1Vildagliptin
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01 17Active
02 19Blank
01 15Valid
02 21Blank
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01 36Blank
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01 10WC-0004
02 2WC-0004A4
03 24Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36534
Submission : 2022-06-16
Status : Active
Type : II
Certificate Number : R0-CEP 2019-006 - Rev 01
Issue Date : 2021-06-01
Type : Chemical
Substance Number : 2531
Status : Valid
Date of Issue : 2022-03-24
Valid Till : 2025-03-17
Written Confirmation Number : WC-0004
Address of the Firm :
NDC Package Code : 49716-329
Start Marketing Date : 2023-10-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-02-05
Pay. Date : 2023-12-22
DMF Number : 36535
Submission : 2022-01-05
Status : Active
Type : II
Certificate Number : CEP 2018-075 - Rev 03
Issue Date : 2023-11-02
Type : Chemical
Substance Number : 1322
Status : Valid
Date of Issue : 2022-03-24
Valid Till : 2025-03-17
Written Confirmation Number : WC-0004
Address of the Firm :
NDC Package Code : 49716-330
Start Marketing Date : 2023-10-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2021-06-22
Registration Number : 20210622-209-J-854
Manufacturer Name : IOL Chemicals and Pharmaceuticals Limited
Manufacturer Address : IOL Chemicals and Pharmaceuticals LimitedVillage Fatehgarh Channa, Mansa Road(Trident Complex)District-BarnalaState-Punjab, 148101India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36536
Submission : 2022-04-29
Status : Active
Type : II
Certificate Number : CEP 2022-188 - Rev 00
Issue Date : 2024-04-04
Type : Chemical
Substance Number : 2173
Status : Valid
Date of Issue : 2022-03-24
Valid Till : 2025-03-17
Written Confirmation Number : WC-0004
Address of the Firm :
NDC Package Code : 49716-326
Start Marketing Date : 2023-10-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-13
Pay. Date : 2014-06-09
DMF Number : 22431
Submission : 2009-01-15
Status : Active
Type : II
Certificate Number : R0-CEP 2021-506 - Rev 01
Issue Date : 2023-01-26
Type : Chemical
Substance Number : 721
Status : Valid
Date of Issue : 2022-03-24
Valid Till : 2025-03-17
Written Confirmation Number : WC-0004
Address of the Firm :
NDC Package Code : 49716-325
Start Marketing Date : 2017-06-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sanil Pharmaceutical Co., Ltd.
Registration Date : 2023-05-24
Registration Number : 20210727-209-J-555(A)
Manufacturer Name : IOL Chemicals and Pharmaceuticals Limited
Manufacturer Address : Village: Fatebgarh Channa, Mansa Road (Trident Complex) Bamala-148101(Punjab) India