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 1HRV Global Life Sciences
08 1Anuh Pharma LTD
09 1Avik Pharmaceutical Limited
10 1Bayer AG
11 1Envee Drugs
12 1Fujifilm Diosynth Biotechnologies
13 1Great Pacific Exports
14 1Gurvey & Berry
15 1Henan Lihua Pharmaceutical
16 1Maharshi Pharma Chem
17 1Mahima Life Sciences
18 2Pfizer Inc
19 2Rumit Group of Companies
20 1SM BIOMED
21 1Symbiotica Specialty Ingredients
22 1Vaishali Pharma Ltd
23 2Zhejiang Xianju Pharmaceutical Co. Ltd
01 1Canada
02 3China
03 1France
04 3Germany
05 15India
06 2Malaysia
07 3U.S.A
08 1United Kingdom
01 4Active
02 4Inactive
03 21Blank
01 6Valid
02 1Withdrawn by Holder
03 22Blank
01 1222MF10090
02 1227MF10269
03 1304MF10022
04 26Blank
01 1WC-0161A2
02 2WC-0162A2
03 1WC-0169
04 1WC-0485A3
05 1WC-247
06 23Blank
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 : 46439-8761
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 : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : AbbVie Korea Co., Ltd.
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 : 2022-07-05
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 : 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
Date of Issue : 2022-09-30
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
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
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-01-04
Pay. Date : 2023-09-01
DMF Number : 28518
Submission : 2014-07-30
Status : Active
Type : II
Certificate Number : R1-CEP 2016-124 - Rev 00
Issue Date : 2022-02-23
Type : Chemical
Substance Number : 734
Status : Valid
NDC Package Code : 64958-0048
Start Marketing Date : 2003-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2024-10-07
Registration Number : 20180412-71-B-402-07(1)
Manufacturer Name : Henan Lihua Pharmaceutical Co.,Ltd.
Manufacturer Address : Middle of Huanghe Street, Anyang Hi-Tech Industry Development Zone, Henan, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1454
Submission : 1969-12-12
Status : Inactive
Type : II
Certificate Number : R0-CEP 2000-271 - Rev 00
Issue Date : 2001-10-24
Type : TSE
Substance Number : 734
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5504
Submission : 1984-06-23
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 : 3949
Submission : 1980-07-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4597
Submission : 1982-06-16
Status : Inactive
Type : II
Date of Issue : 2021-08-13
Valid Till : 2023-09-24
Written Confirmation Number : WC-0485A3
Address of the Firm :
Registration Number : 304MF10022
Registrant's Address : No. 1 Xianyao Road, Xianju, Zhejiang, China
Initial Date of Registration : 2022-01-26
Latest Date of Registration :
NDC Package Code : 60722-3006
Start Marketing Date : 2020-10-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registration Number : 227MF10269
Registrant's Address : No. 1 Xianyao Road, Xianju, Zhejiang, China
Initial Date of Registration : 2015-11-19
Latest Date of Registration :
NDC Package Code : 60722-3006
Start Marketing Date : 2020-10-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2019-06-27
Valid Till : 2022-07-02
Written Confirmation Number : WC-0169
Address of the Firm :
Certificate Number : R1-CEP 2014-138 - Rev 00
Issue Date : 2022-06-20
Type : Chemical
Substance Number : 734
Status : Valid
NDC Package Code : 52128-150
Start Marketing Date : 2010-11-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2021-03-02
Registration Number : 20210302-71-B-441-11
Manufacturer Name : Symbiotica Specialty Ingredients Sdn. Bhd@Tianjin Tianyao Pharmaceuticals Co., Ltd
Manufacturer Address : No. 518, Jalan Waja 4, Taman Industri Waja, 09000 Kulim, Kedah, Malaysia@No.19 Xinye 9th Street, west Area of Tianjin Economic-Technological Development Area, Tianjin, China
Date of Issue : 2022-06-28
Valid Till : 2025-07-02
Written Confirmation Number : WC-247
Address of the Firm :
A Prednisolone Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prednisolone Acetate, including repackagers and relabelers. The FDA regulates Prednisolone Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prednisolone Acetate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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