Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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01 3Symbiotec Pharmalab
02 1Bioquim
03 1Gonane Pharma
04 1Axplora
05 1EUROAPI
06 1HRV Global Life Sciences
07 1Avik Pharmaceutical Limited
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12 1Guangzhou Tosun Pharmaceutical
13 2Henan Lihua Pharmaceutical
14 1Human Pharmalabs
15 1Laboratorio Syntex S.A
16 1Mac-Chem Products (India) Pvt.Ltd
17 1Maharshi Pharma Chem
18 1Micro Orgo Chem
19 1Pcca
20 2Pfizer Inc
21 1Quimica Sintetica
22 1SIMS Srl
23 1Spectrum Chemical
24 1Sterling Spa
25 4Tianjin Tianfa Pharmaceutical Import & Export
26 1Vaishali Pharma Ltd
27 5Zhejiang Xianju Pharmaceutical Co. Ltd
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01 1Argentina
02 12China
03 1France
04 2Germany
05 12India
06 2Italy
07 2Spain
08 4U.S.A
09 3United Kingdom
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01 9Active
02 7Inactive
03 23Blank
01 1Expired
02 6Valid
03 1Withdrawn by Holder
04 31Blank
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01 39Blank
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01 1WC-0162A2
02 1WC-0485
03 37Blank
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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 120250318-209-J-1826
15 25Blank
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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 29Blank
01 39Blank
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
Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
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
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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