Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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01 3Symbiotec Pharmalab
02 1Gonane Pharma
03 1Axplora
04 1EUROAPI
05 1HRV Global Life Sciences
06 1Avik Pharmaceutical Limited
07 1Bayer AG
08 1Curia
09 2Fujifilm Diosynth Biotechnologies
10 1Guangzhou Tosun Pharmaceutical
11 1Henan Lihua Pharmaceutical
12 1Human Pharmalabs
13 1Laboratorio Syntex S.A
14 1Mac-Chem Products (India) Pvt.Ltd
15 1Maharshi Pharma Chem
16 1Micro Orgo Chem
17 1Pcca
18 2Pfizer Inc
19 1Quimica Sintetica
20 1SIMS Srl
21 1Spectrum Chemical
22 1Sterling Spa
23 4Tianjin Tianfa Pharmaceutical Import & Export
24 1Vaishali Pharma Ltd
25 5Zhejiang Xianju Pharmaceutical Co. Ltd
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01 1Argentina
02 11China
03 1France
04 2Germany
05 11India
06 2Italy
07 1Spain
08 4U.S.A
09 3United Kingdom
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01 8Active
02 7Inactive
03 21Blank
01 1Expired
02 6Valid
03 1Withdrawn by Holder
04 28Blank
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01 36Blank
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01 1WC-0162A2
02 1WC-0485
03 34Blank
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01 120180116-209-J-2
02 120180116-209-J-2(1)
03 120180116-209-J-2(2)
04 120180116-209-J-2(3)
05 120180706-209-J-239
06 120180706-209-J-239(1)
07 120180706-209-J-239(2)
08 120180706-209-J-239(3)
09 120210715-209-J-1022
10 120210715-209-J-1022(1)
11 120210715-209-J-1022(2)
12 120221024-209-J-1384
13 120240326-209-J-1628
14 23Blank
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01 10009-0038
02 122552-0029
03 149452-4686
04 151927-0201
05 157582-011
06 160722-1003
07 164918-1917
08 164958-0084
09 165089-0062
10 182298-118
11 26Blank
01 36Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-21
Pay. Date : 2013-12-17
DMF Number : 27783
Submission : 2013-11-25
Status : Active
Type : II
Certificate Number : R1-CEP 2014-015 - Rev 01
Issue Date : 2022-05-03
Type : Chemical
Substance Number : 561
Status : Valid
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
NDC Package Code : 22552-0029
Start Marketing Date : 2011-08-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2023-01-11
Registration Number : 20210715-209-J-1022(2)
Manufacturer Name : Symbiotec Pharmalab Private Limited
Manufacturer Address : Plot No: 5, 6, 7 & 8, Special Economic Zone, Phase-II, Pharma zone, Pithampur, Dist. Dhar - 454 774(MP), India
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-01
Pay. Date : 2013-12-10
DMF Number : 3771
Submission : 1980-04-15
Status : Active
Type : II
Certificate Number : R1-CEP 1996-018 - Rev 09
Issue Date : 2021-12-16
Type : Chemical
Substance Number : 561
Status : Valid
NDC Package Code : 82298-118
Start Marketing Date : 2011-02-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34637
Submission : 2020-11-05
Status : Active
Type : II
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2021-12-24
Registration Number : 20210715-209-J-1022(1)
Manufacturer Name : Symbiotec Pharmalab Private Limited
Manufacturer Address : Plot No: 5, 6, 7 & 8, Special Economic Zone, Phase-II, Pharma zone, Pithampur, Dist. Dhar - 454 774(MP), India
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2021-07-15
Registration Number : 20210715-209-J-1022
Manufacturer Name : Symbiotec Pharmalab Private Limited
Manufacturer Address : Plot No: 5, 6, 7 & 8, Special Economic Zone, Phase-II, Pharma zone, Pithampur, Dist. Dhar - 454 774(MP), India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17547
Submission : 2004-07-19
Status : Active
Type : II
Certificate Number : R1-CEP 2012-307 - Rev 01
Issue Date : 2022-10-04
Type : Chemical
Substance Number : 561
Status : Valid
NDC Package Code : 57582-011
Start Marketing Date : 2015-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2021-12-17
Registration Number : 20180706-209-J-239(3)
Manufacturer Name : Tianjin Tianyao Pharmaceuticals Co., Ltd
Manufacturer Address : No.19 Xinye 9th Street, west Area of Tianjin Economic-Technological Development Area, Tianjin, China.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3592
Submission : 1979-08-06
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3636
Submission : 1979-11-02
Status : Inactive
Type : II
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