Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 3Symbiotec Pharmalab
02 1Gonane Pharma
03 2Axplora
04 1EUROAPI
05 1Transo-Pharm USA LLC
06 1Vamsi Labs
07 1Cennet Biopharma
08 1HRV Global Life Sciences
09 1Anuh Pharma LTD
10 1Avik Pharmaceutical Limited
11 1Bayer AG
12 1Envee Drugs
13 1Fujifilm Diosynth Biotechnologies
14 1Great Pacific Exports
15 1Gurvey & Berry
16 1Henan Lihua Pharmaceutical
17 1Maharshi Pharma Chem
18 1Mahima Life Sciences
19 2Pfizer Inc
20 2Rumit Group of Companies
21 1SM BIOMED
22 1Symbiotica Specialty Ingredients
23 1Vaishali Pharma Ltd
24 2Zhejiang Xianju Pharmaceutical Co. Ltd
01 1Canada
02 3China
03 1France
04 3Germany
05 16India
06 2Malaysia
07 3U.S.A
08 1United Kingdom
01 4Active
02 4Inactive
03 22Blank
01 6Valid
02 1Withdrawn by Holder
03 23Blank
01 1222MF10090
02 1227MF10269
03 1304MF10022
04 27Blank
01 1WC-0161
02 1WC-0161A2
03 1WC-0162
04 1WC-0169
05 1WC-0485A3
06 1WC-247
07 24Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-05-19
Pay. Date : 2020-04-13
DMF Number : 32728
Submission : 2018-06-04
Status : Active
Type : II
Certificate Number : CEP 2018-089 - Rev 02
Issue Date : 2024-07-29
Type : Chemical
Substance Number : 734
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 : 22552-0044
Start Marketing Date : 2015-10-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2023-06-22
Registration Number : 20230622-71-B-473-12
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 : 2020-12-29
Pay. Date : 2020-09-22
DMF Number : 32896
Submission : 2018-07-16
Status : Active
Type : II
Certificate Number : R0-CEP 2019-109 - Rev 00
Issue Date : 2020-06-02
Type : Chemical
Substance Number : 734
Status : Valid
NDC Package Code : 46439-8761
Start Marketing Date : 2018-05-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-02-01
Pay. Date : 2023-01-30
DMF Number : 3529
Submission : 1979-05-30
Status : Active
Type : II
Certificate Number : R1-CEP 2000-025 - Rev 06
Issue Date : 2021-12-16
Type : Chemical
Substance Number : 734
Status : Valid
Registration Number : 222MF10090
Registrant's Address : 82 Avenue Raspail 94250 Gentilly France
Initial Date of Registration : 2010-03-17
Latest Date of Registration : --
NDC Package Code : 82298-107
Start Marketing Date : 2011-02-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : AbbVie Korea Inc.
Registration Date : 2019-11-26
Registration Number : 20191126-71-B-422-09
Manufacturer Name : EUROAPI France
Manufacturer Address : 4 La Paterie, VERTOLAYE, 63480 France
Available Reg Filing : ROW |
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162
Address of the Firm :
NDC Package Code : 22552-0044
Start Marketing Date : 2015-10-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2023-06-22
Registration Number : 20230622-71-B-473-12
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
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0044
Start Marketing Date : 2015-10-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2023-06-22
Registration Number : 20230622-71-B-473-12
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
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