01 1Adare Pharma Solutions
02 1Aurorium
03 1Brenntag
04 1Cahaya Mandiri Farma
05 1Chemtrade Solutions LLC
06 1EURAND
07 1F. Hoffmann-La Roche
08 1Glenmark Life Sciences
09 1Global Calcium
10 1India Phosphate
11 1Ishita Drugs & Industries
12 1K+S Kali GmbH
13 1K+S Minerals and Agriculture
14 1Klinge Chemicals Ltd
15 2Macco Organiques, Spol. s.r o
16 1Mallinckrodt Pharmaceuticals
17 1Manac Incorporated
18 2Morton Salt
19 1Nandu Chemicals
20 1Nitika Pharmaceutical Specialities
21 1Salvi Chemical Industries
22 1THINQ Pharma-CRO PVT Ltd
23 2Tomita Pharmaceutical
24 1Uji Pharmaceutical
25 1VM Chemicals
26 1Valaji PharmaChem
27 1Wuhan Shiji Pharmaceutical
28 1Yangzhou Gami Biochem Co. Ltd
01 1Canada
02 2China
03 2Czech Republic
04 2Germany
05 10India
06 1Indonesia
07 1Ireland
08 4Japan
09 2Switzerland
10 5U.S.A
11 1United Kingdom
01 12Active
02 5Inactive
03 14Blank
01 4Valid
02 27Blank
01 1217MF10517
02 1217MF10592
03 1217MF10675
04 1227MF10169
05 1301MF10006
06 1306MF10055
07 25Blank
01 1WC-0310
02 1WC-0452
03 29Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36874
Submission : 2023-03-14
Status : Active
Type : II
NDC Package Code : 64162-0075
Start Marketing Date : 2022-10-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-07-13
Pay. Date : 2018-05-25
DMF Number : 30511
Submission : 2016-10-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29040
Submission : 2015-01-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25840
Submission : 2011-11-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6118
Submission : 1985-12-12
Status : Active
Type : II
NDC Package Code : 59917-054
Start Marketing Date : 1985-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (0.87kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31771
Submission : 2017-09-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5617
Submission : 1984-10-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20616
Submission : 2007-06-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8996
Submission : 1991-02-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2818
Submission : 1977-01-03
Status : Inactive
Type : II
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