Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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01 4China
02 1Germany
03 24India
04 2Israel
05 3Italy
06 3Malaysia
07 1Mexico
08 1Portugal
09 1Singapore
10 1Spain
11 4U.S.A
12 2United Kingdom
13 1Blank
01 9Active
02 7Inactive
03 32Blank
01 8Valid
02 40Blank
01 1218MF10277
02 1218MF10459
03 1218MF10865
04 1218MF10900
05 1219MF10367
06 1225MF10196
07 42Blank
01 1WC-0161
02 1WC-0161A2
03 1WC-0162
04 1WC-0169
05 1WC-0429
06 1WC-241
07 1WC-247
08 41Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-02
Pay. Date : 2016-02-12
DMF Number : 25798
Submission : 2012-02-16
Status : Active
Type : II
Certificate Number : R1-CEP 2012-079 - Rev 00
Issue Date : 2018-02-19
Type : Chemical
Substance Number : 809
Status : Valid
Date of Issue : 2022-09-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161
Address of the Firm :
NDC Package Code : 22552-0028
Start Marketing Date : 2011-08-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-07
Pay. Date : 2013-09-26
DMF Number : 23118
Submission : 2009-09-16
Status : Active
Type : II
Certificate Number : R1-CEP 2003-232 - Rev 03
Issue Date : 2023-02-08
Type : Chemical
Substance Number : 809
Status : Valid
NDC Package Code : 46439-8710
Start Marketing Date : 1989-05-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Available Reg Filing : SAU |
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-04-13
Pay. Date : 2015-04-02
DMF Number : 4148
Submission : 1981-04-28
Status : Active
Type : II
Available Reg Filing : CA, ASMF |
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162
Address of the Firm :
NDC Package Code : 22552-0028
Start Marketing Date : 2011-08-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0028
Start Marketing Date : 2011-08-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24486
Submission : 2010-10-12
Status : Active
Type : II
Certificate Number : R1-CEP 2011-005 - Rev 01
Issue Date : 2017-12-12
Type : Chemical
Substance Number : 809
Status : Valid
NDC Package Code : 52128-160
Start Marketing Date : 2011-11-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2021-12-21
Registration Number : 20211221-211-J-1097
Manufacturer Name : Symbiotica Specialty Ingredients Sdn. Bhd.
Manufacturer Address : No. 518, Jalan Waja 4, Taman Industri Waja, 09000 Kulim, Kedah, Malaysia
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