Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Jai Radhe Sales
03 1HRV Global Life Sciences
04 1ALP Pharm
05 1Alkem Laboratories
06 1Apotex Pharmachem
07 1Aurobindo Pharma Limited
08 1CHEMO
09 2Cipla
10 1Dr. Raju’s Pharma Solutions
11 1Emcure Pharmaceuticals
12 1Glenmark Life Sciences
13 1Glenmark Pharmaceuticals
14 1Guangzhou Tosun Pharmaceutical
15 1Hetero Drugs
16 1Jubilant Generics
17 1Jubilant Pharmova
18 1Macleods Pharmaceuticals Limited
19 2Natco Pharma
20 1Nosch Labs Pvt
21 1Phalanx Labs
22 1SMS Pharmaceuticals
23 1Sun Pharmaceutical Industries Limited
24 1Syn-Tech Chem. & Pharm
25 1Synergene Active Ingredients Pvt Ltd
26 1Tianish Laboratories
27 1Unichem Laboratories Limited
28 1Unimark Remedies Limited
29 1Viatris
30 1Zhejiang Supor Pharmaceuticals Co., LTD
01 1Canada
02 3China
03 23India
04 2Spain
05 1Taiwan
06 2U.S.A
01 18Active
02 3Inactive
03 11Blank
01 11Valid
02 1Withdrawn by Holder
03 20Blank
01 1227MF10229
02 1227MF10282
03 1228MF10019
04 1228MF10064
05 28Blank
01 1WC-0014
02 1WC-0023
03 1WC-0027
04 1WC-0057n
05 1WC-0063
06 1WC-0066
07 1WC-0071
08 1WC-0079
09 1WC-0092
10 1WC-0117
11 1WC-0128
12 1WC-0144nA2
13 1WC-0168
14 1WC-0170
15 1WC-0226
16 1WC-0370n
17 16Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25623
Submission : 2011-12-22
Status : Active
Type : II
NDC Package Code : 64567-0013
Start Marketing Date : 2009-10-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-11
Pay. Date : 2015-09-03
DMF Number : 19098
Submission : 2006-01-10
Status : Active
Type : II
Registration Number : 227MF10282
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2015-12-15
Latest Date of Registration : --
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
NDC Package Code : 65015-653
Start Marketing Date : 2015-01-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-18
Pay. Date : 2013-05-24
DMF Number : 23066
Submission : 2009-08-26
Status : Active
Type : II
Certificate Number : R1-CEP 2013-028 - Rev 00
Issue Date : 2020-05-18
Type : Chemical
Substance Number : 2585
Status : Valid
Registration Number : 228MF10019
Registrant's Address : Plot No. 72, H. No.8-2-334/3&4 Road No. 5, Opp. SBI Executive Enclave, Banjara Hills, Hyderabad, Telangana, India
Initial Date of Registration : 2016-01-14
Latest Date of Registration : --
Date of Issue : 2019-06-26
Valid Till : 2022-07-02
Written Confirmation Number : WC-0071
Address of the Firm :
NDC Package Code : 67835-5016
Start Marketing Date : 2009-05-13
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 : 23598
Submission : 2010-02-23
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-06-02
Pay. Date : 2021-05-27
DMF Number : 20781
Submission : 2007-08-21
Status : Active
Type : II
Certificate Number : R1-CEP 2012-268 - Rev 00
Issue Date : 2020-05-15
Type : Chemical
Substance Number : 2585
Status : Valid
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0014
Address of the Firm :
NDC Package Code : 63850-7119
Start Marketing Date : 2016-01-18
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 : 22763
Submission : 2009-05-08
Status : Active
Type : II
NDC Package Code : 63850-7119
Start Marketing Date : 2016-01-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-28
Pay. Date : 2014-03-06
DMF Number : 27991
Submission : 2014-03-11
Status : Active
Type : II
Certificate Number : R1-CEP 2014-290 - Rev 00
Issue Date : 2021-09-16
Type : Chemical
Substance Number : 2585
Status : Valid
Date of Issue : 2019-07-29
Valid Till : 2022-07-28
Written Confirmation Number : WC-0063
Address of the Firm :
NDC Package Code : 53747-043
Start Marketing Date : 2014-03-11
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 : 28634
Submission : 2014-09-08
Status : Active
Type : II
Registration Number : 227MF10229
Registrant's Address : No. 168 Kai-Yuan Rd. , Hsin-Ying Tainan City, 73055. Taiwan
Initial Date of Registration : 2015-09-03
Latest Date of Registration : --
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