Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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01 3Symbiotec Pharmalab
02 1Gonane Pharma
03 2Axplora
04 2EUROAPI
05 1Transo-Pharm USA LLC
06 1Vamsi Labs
07 1HRV Global Life Sciences
08 1Anuh Pharma LTD
09 1Avik Pharmaceutical Limited
10 1Bayer AG
11 1Envee Drugs
12 1Fujifilm Diosynth Biotechnologies
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14 1Gurvey & Berry
15 2Henan Lihua Pharmaceutical
16 1Human Pharmalabs
17 1Maharshi Pharma Chem
18 1Mahima Life Sciences
19 1Medisca
20 2Pfizer Inc
21 2Rumit Group of Companies
22 1SM BIOMED
23 1Spectrum Chemical
24 1Symbiotica Specialty Ingredients
25 1Tianjin Tianfa Pharmaceutical Import & Export
26 1Vaishali Pharma Ltd
27 2Zhejiang Xianju Pharmaceutical Co. Ltd
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01 1Canada
02 5China
03 2France
04 3Germany
05 16India
06 2Malaysia
07 5U.S.A
08 1United Kingdom
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01 4Active
02 4Inactive
03 27Blank
01 6Valid
02 1Withdrawn by Holder
03 28Blank
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01 1222MF10090
02 1227MF10269
03 1304MF10022
04 32Blank
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01 1WC-0161A2
02 2WC-0162A2
03 1WC-0169
04 1WC-0485A3
05 1WC-247
06 29Blank
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01 120180412-71-B-402-07
02 120180412-71-B-402-07(1)
03 120191126-71-B-422-09
04 120210302-71-B-441-11
05 120230622-71-B-473-12
06 30Blank
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01 122552-0044
02 138779-0152
03 146439-8761
04 146439-8776
05 149452-5990
06 152128-150
07 160722-3006
08 164958-0048
09 182298-107
10 182298-108
11 25Blank
01 35Blank
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 : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
NDC Package Code : 22552-0044
Start Marketing Date : 2015-10-26
End Marketing Date : 2025-12-31
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 : 46439-8776
Start Marketing Date : 2024-09-23
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 : 2025-12-31
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
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
Date of Issue : 2022-09-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
Certificate Number : CEP 2017-286 - Rev 02
Issue Date : 2024-07-25
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
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We have 27 companies offering Prednisolone Acetate
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