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03 1Brenntag
04 1Cahaya Mandiri Farma
05 1Chemtrade Solutions LLC
06 1EURAND
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08 1Glenmark Life Sciences
09 1Global Calcium
10 1India Phosphate
11 1Ishita Drugs & Industries
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14 1Klinge Chemicals Ltd
15 2Macco Organiques, Spol. s.r o
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01 1217MF10517
02 1217MF10592
03 1217MF10675
04 1227MF10169
05 1301MF10006
06 1306MF10055
07 25Blank
01 1WC-0310
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GDUFA
DMF Review : N/A
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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
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GDUFA
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DMF Number : 25840
Submission : 2011-11-22
Status : Active
Type : II
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Rev. Date : 2015-01-05
Pay. Date : 2014-11-03
DMF Number : 28651
Submission : 2014-11-03
Status : Active
Type : II
Date of Issue : 2023-12-28
Valid Till : 2026-12-28
Written Confirmation Number : WC-0310
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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
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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
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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
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DMF Number : 31771
Submission : 2017-09-06
Status : Active
Type : IV
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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
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DMF Number : 2818
Submission : 1977-01-03
Status : Inactive
Type : II
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DMF Number : 20616
Submission : 2007-06-18
Status : Inactive
Type : II
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DMF Number : 8996
Submission : 1991-02-25
Status : Inactive
Type : II
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