01 1M/s Aurore Pharmaceuticals Private Limited
02 1M/s Enaltec Labs Private Limited
03 1M/s Glenmark Life Sciences Limited
04 1M/s MSN Laboratories Private Limited
05 1M/s. Alembic Pharmaceuticals Limited
06 1M/s. Lupin Limited.
07 1M/s. MSN Laboratories Pvt. Ltd.,
08 1M/s. Symed Labs Limited
09 1M/s. Unimark Remedies Limited
10 1M/sAlembic Pharmaceuticals Limited API Division
01 1Dronedarone HCl IH
02 1Dronedarone HCl USP
03 2Dronedarone Hydrochloride
04 1Dronedarone Hydrochloride Ph.Eur IUSP
05 5Dronedarone Hydrochloride IH
01 1WC-0021
02 1WC-0021n
03 1WC-0049
04 1WC-0057n
05 1WC-0072
06 1WC-0082
07 1WC-0082A5
08 1WC-0119
09 1WC-0170
10 1WC-0424
01 10India
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm : API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, G...
Date of Issue : 2019-10-22
Valid Till : 2022-07-02
Written Confirmation Number : WC-0082A5
Address of the Firm : API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, G...
Dronedarone Hydrochloride Ph.Eur IUSP
Date of Issue : 2022-09-19
Valid Till : 2025-07-02
Written Confirmation Number : WC-0119
Address of the Firm : Plot No. 35, 36, 38, 39,40,49, 50 & 51, Phase-IV, IDA, Jeedimetla, Medchal- Malk...
Date of Issue : 2018-12-03
Valid Till : 2021-07-09
Written Confirmation Number : WC-0424
Address of the Firm : Plot no. 61 Additional Ambernath Ambernath East Dist. Thane 421506 Maharashtra
Date of Issue : 2022-06-07
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm : Plot No. 3109, GIDC, Industrial Estate, Ankleshwar-393 002, Bharuch, Gujarat
Date of Issue : 2022-06-07
Valid Till : 2025-06-16
Written Confirmation Number : WC-0049
Address of the Firm : Block 21, Dabhasa, Padra Taluka, Vadodara-391 440
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm : Sy. Nos: 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Man...
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0021
Address of the Firm : Sy. No.317&323, Rudraram Village, Patancheru Mandal, Sangaredy District-502329 T...
Date of Issue : 2019-10-07
Valid Till : 2022-09-08
Written Confirmation Number : WC-0072
Address of the Firm : Plot No. 25/B, Phase-III, I.D.A., Jeedimetla, Hyderabad-500 055. AP.
Date of Issue : 2024-04-23
Valid Till : 2027-04-22
Written Confirmation Number : WC-0170
Address of the Firm : Plot No. 41, 42/2, 42/1/b, 43, 40, 59, 58, GIDC, Vapi, Dist-Valsad, Gujarat, Ind...
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