01 1Adare Pharma Solutions
02 1Aurorium
03 1Brenntag
04 1Chemtrade Solutions LLC
05 1EURAND
06 1F. Hoffmann-La Roche
07 1Glenmark Life Sciences
08 1Global Calcium
09 1India Phosphate
10 1Ishita Drugs & Industries
11 1K+S Kali GmbH
12 1K+S Minerals and Agriculture
13 1Klinge Chemicals Ltd
14 2Macco Organiques, Spol. s.r o
15 1Mallinckrodt Pharmaceuticals
16 1Manac Incorporated
17 2Morton Salt
18 1Nandu Chemicals
19 1Nitika Pharmaceutical Specialities
20 1Salvi Chemical Industries
21 1THINQ Pharma-CRO PVT Ltd
22 2Tomita Pharmaceutical
23 1Uji Pharmaceutical
24 1VM Chemicals
25 1Valaji PharmaChem
26 1Wuhan Shiji Pharmaceutical
27 1Yangzhou Gami Biochem Co. Ltd
01 1Canada
02 2China
03 2Czech Republic
04 2Germany
05 10India
06 1Ireland
07 4Japan
08 2Switzerland
09 5U.S.A
10 1United Kingdom
01 12Active
02 5Inactive
03 13Blank
01 4Valid
02 26Blank
01 1217MF10517
02 1217MF10592
03 1217MF10675
04 1227MF10169
05 1301MF10006
06 1306MF10055
07 24Blank
01 1WC-0310
02 1WC-0452
03 28Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31851
Submission : 2017-09-12
Status : Active
Type : II
Certificate Number : R0-CEP 2018-159 - Rev 00
Issue Date : 2020-02-19
Type : Chemical
Substance Number : 185
Status : Valid
Registration Number : 306MF10055
Registrant's Address : Zahradni(') 46c,792 01 Brunta(')l, Czech Republic
Initial Date of Registration : 2024-04-10
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-05
Pay. Date : 2014-11-03
DMF Number : 28651
Submission : 2014-11-03
Status : Active
Type : II
Date of Issue : 2021-01-08
Valid Till : 2023-11-23
Written Confirmation Number : WC-0310
Address of the Firm :
NDC Package Code : 66039-910
Start Marketing Date : 2014-11-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : Reviewed
Rev. Date : 2023-11-13
Pay. Date : 2023-09-22
DMF Number : 38573
Submission : 2023-09-29
Status : Active
Type : II
NDC Package Code : 54469-0008
Start Marketing Date : 2023-08-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 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 : 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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20616
Submission : 2007-06-18
Status : Inactive
Type : II
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