Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 3Symbiotec Pharmalab
02 1Axplora
03 1Gonane Pharma
04 1Jai Radhe Sales
05 1TAPI Technology & API Services
06 1ACS DOBFAR SPA
07 1Anuh Pharma LTD
08 1Arudavis Labs
09 1Aurisco Pharmaceutical
10 1Avik Pharmaceutical Limited
11 1Balaji Corporation
12 1Bayer AG
13 1Bazayan & Co
14 1Curia
15 1Envee Drugs
16 1Fujifilm Diosynth Biotechnologies
17 2GSK
18 1Globofarm International
19 1Great Pacific Exports
20 1Guangzhou Topwork Chemical
21 1Halcyon Labs Private Limited
22 1Henan Lihua Pharmaceutical
23 1Hovione
24 1MSD INTL GMBH
25 1Maharshi Pharma Chem
26 1Mahima Life Sciences
27 1NEWCHEM SPA
28 1Pfizer Inc
29 1Quimica Sintetica
30 2Rumit Group of Companies
31 1SM BIOMED
32 1Sicor Societa Italiana Corticosteroidi Srl
33 1Sneha Medicare Pvt Ltd
34 1Sudarshan Pharma
35 1Symbiotica Specialty Ingredients
36 1Taro Pharmaceutical Industries
37 1Teva Pharmaceutical Industries
38 1Unimax Group
39 1Vaishali Pharma Ltd
40 1Zhejiang Xianju Pharmaceutical Co. Ltd
41 1Blank
01 4China
02 2Germany
03 22India
04 2Israel
05 3Italy
06 2Malaysia
07 1Portugal
08 1Singapore
09 1Spain
10 3U.S.A
11 3United Kingdom
12 1Blank
01 7Active
02 11Inactive
03 27Blank
01 1Expired
02 9Valid
03 1Withdrawn by Holder
04 34Blank
01 1218MF10539
02 1218MF10825
03 1222MF10158
04 1304MF10098
05 41Blank
01 1WC-0161
02 1WC-0161A2
03 1WC-0162
04 1WC-0169
05 1WC-0429
06 1WC-241
07 1WC-247
08 38Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-01
Pay. Date : 2014-04-29
DMF Number : 22062
Submission : 2008-10-07
Status : Active
Type : II
Certificate Number : R1-CEP 2008-307 - Rev 00
Issue Date : 2016-04-08
Type : Chemical
Substance Number : 811
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 : 22552-0005
Start Marketing Date : 2017-12-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-08-14
Pay. Date : 2018-07-09
DMF Number : 12749
Submission : 1997-11-18
Status : Active
Type : II
Certificate Number : R1-CEP 2002-078 - Rev 03
Issue Date : 2021-03-22
Type : Chemical
Substance Number : 811
Status : Valid
Registration Number : 304MF10098
Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy
Initial Date of Registration : 2022-07-06
Latest Date of Registration : --
NDC Package Code : 46439-8711
Start Marketing Date : 1989-05-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-29
Pay. Date : 2014-05-21
DMF Number : 4118
Submission : 1981-04-09
Status : Active
Type : II
Certificate Number : R1-CEP 2003-095 - Rev 04
Issue Date : 2021-11-25
Type : Chemical
Substance Number : 811
Status : Valid
Available Reg Filing : ASMF |
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0005
Start Marketing Date : 2017-12-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162
Address of the Firm :
NDC Package Code : 22552-0005
Start Marketing Date : 2017-12-12
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 : 27210
Submission : 2013-06-03
Status : Inactive
Type : II
Certificate Number : R1-CEP 2008-215 - Rev 00
Issue Date : 2015-06-26
Type : Chemical
Substance Number : 811
Status : Valid
NDC Package Code : 52128-162
Start Marketing Date : 2011-11-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22651
Submission : 2008-12-09
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 : 5554
Submission : 1984-10-11
Status : Inactive
Type : II
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