Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
01 1Octavius Pharma Pvt. Ltd
02 1IOL Chemicals and Pharmaceuticals
03 1Moehs Iberica
04 1Ami Lifesciences Private Limited
05 1Alembic Pharmaceuticals Limited
06 1CordenPharma
07 1Curia
08 1Glenmark Life Sciences
09 1Guangzhou Tosun Pharmaceutical
10 1Harman Finochem
11 1Hunan Warrant Chiral Pharmaceutical
12 1Indian Drugs And Chemicals
13 1Laboratorio Chimico Internazionale Spa
14 1Lupin Ltd
15 1Olon S.p.A
16 1Om Pharmaceutical Industries
17 1Omshri Labs
18 1Pellsys Pharma
19 1Teva API
01 2China
02 1Germany
03 11India
04 1Israel
05 2Italy
06 1Spain
07 1U.S.A
01 9Active
02 10Blank
01 19Blank
01 19Blank
01 1WC-0045
02 1WC-0054
03 1WC-0057n
04 1WC-0081
05 1WC-0201
06 14Blank
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-03-30
Pay. Date : 2014-10-09
DMF Number : 24540
Submission : 2011-01-07
Status : Active
Type : II
NDC Package Code : 68294-0003
Start Marketing Date : 2009-07-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Wooshin Rabotachi Co., Ltd.
Registration Date : 2020-07-14
Registration Number : 20200714-209-J-482
Manufacturer Name : COPRIMA SL
Manufacturer Address : c/Pablo Picasso, 15 08213 Polinya (Barcelona), Spain
Date of Issue : 2022-08-11
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm :
Registrant Name : Leaders Bio Co., Ltd.
Registration Date : 2019-05-07
Registration Number : 20190507-209-J-344
Manufacturer Name : Ami Lifesciences Private Limited @[Starting material ‘fenofibric acid’ manufacturing plant ①] Alembic Limited@[Starting material ‘fenofibric acid’ manufacturing plant ②] Delta Finochem Private Limited
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State India_x000D_ @[Starting material ‘fenofibric acid’ manufacturing plant ①] Alembic Road, Vadodara City : Vadodara-390 003, Dist : Vadodara Gujarat State India@ [Starting material ‘fenofibric acid’ manufacturing plant ②] GAT No. 350, Wadiw Arhe, Igatpuri, Nashik-422403, Dist - Nashik Z-2 District, India_x000D_
Available Reg Filing : MX |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20950
Submission : 2007-10-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23540
Submission : 2010-02-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23048
Submission : 2009-09-30
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-09-10
Written Confirmation Number : WC-0201
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24524
Submission : 2011-01-19
Status : Active
Type : II
Date of Issue : 2022-06-07
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm :
NDC Package Code : 66039-874
Start Marketing Date : 2011-08-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-07-21
Pay. Date : 2017-06-21
DMF Number : 23268
Submission : 2009-11-13
Status : Active
Type : II
NDC Package Code : 17337-0013
Start Marketing Date : 2012-12-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samo Pharmaceutical Co., Ltd.
Registration Date : 2020-02-12
Registration Number : 20200212-209-J-275
Manufacturer Name : OLON SpA@[Manufactory of Intermediate 'Fenofibric Acid'] Derivados Quimicos SAU
Manufacturer Address : Via Benvenuto Cellini, 20, 20054 Segrate, Milano, Italy@[Manufactory of Intermediate 'Fenofibric Acid'] Camino de Pliego, 150 30820 Alcantarilla, Murcia, Spain
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-10
Pay. Date : 2013-09-30
DMF Number : 23464
Submission : 2010-01-14
Status : Active
Type : II
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