Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 3Symbiotec Pharmalab
02 1Gonane Pharma
03 1Axplora
04 1EUROAPI
05 1Sanofi
06 1HRV Global Life Sciences
07 1ACS DOBFAR SPA
08 1Avik Pharmaceutical Limited
09 1Bayer AG
10 1Curia
11 1DEAFARMA
12 1Fujifilm Diosynth Biotechnologies
13 1Guangzhou Topwork Chemical
14 1Guangzhou Tosun Pharmaceutical
15 1Hikma Pharmaceuticals
16 1Laboratorio Syntex S.A
17 1Maharshi Pharma Chem
18 1Mahima Life Sciences
19 1Micro Orgo Chem
20 1NEWCHEM SPA
21 1Pfizer Inc
22 1Rumit Group of Companies
23 1SIMS Srl
24 1Symbiotica Specialty Ingredients
25 1Tianjin Tianyao Pharmaceuticals Co., Ltd.
26 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 1Argentina
02 4China
03 2France
04 2Germany
05 10India
06 4Italy
07 1Malaysia
08 2U.S.A
09 2United Kingdom
01 7Active
02 5Inactive
03 16Blank
01 2Valid
02 1Withdrawn by Holder
03 25Blank
01 28Blank
01 1WC-0161A2
02 2WC-0162A2
03 25Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24611
Submission : 2011-02-03
Status : Active
Type : II
Certificate Number : R1-CEP 2011-063 - Rev 01
Issue Date : 2021-05-12
Type : Chemical
Substance Number : 933
Status : Valid
Date of Issue : 2022-09-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
NDC Package Code : 22552-0023
Start Marketing Date : 2011-08-08
End Marketing Date : 2025-12-31
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 : 2014-06-23
Pay. Date : 2013-12-31
DMF Number : 27325
Submission : 2013-07-19
Status : Active
Type : II
Certificate Number : R0-CEP 2021-429 - Rev 00
Issue Date : 2023-06-23
Type : Chemical
Substance Number : 933
Status : Valid
NDC Package Code : 46439-8767
Start Marketing Date : 2018-11-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : EU |
NDC Package Code : 82298-117
Start Marketing Date : 2011-02-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3452
Submission : 1979-02-08
Status : Active
Type : II
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
NDC Package Code : 22552-0023
Start Marketing Date : 2011-08-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0023
Start Marketing Date : 2011-08-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4813
Submission : 1983-01-06
Status : Active
Type : II
Certificate Number : R0-CEP 2000-363 - Rev 00
Issue Date : 2001-10-24
Type : TSE
Substance Number : 933
Status : Withdrawn by Holder
NDC Package Code : 0009-0026
Start Marketing Date : 2014-07-03
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 : 18956
Submission : 2006-01-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30789
Submission : 2016-07-27
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-07
Pay. Date : 2015-09-24
DMF Number : 23820
Submission : 2010-05-19
Status : Active
Type : II
NDC Package Code : 65089-0016
Start Marketing Date : 1979-03-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 415
Submission : 1960-12-21
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 : 3596
Submission : 1979-08-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4634
Submission : 1982-08-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2688
Submission : 1976-05-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4516
Submission : 1982-05-04
Status : Inactive
Type : II
NDC Package Code : 24002-0010
Start Marketing Date : 2009-08-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 60722-1007
Start Marketing Date : 2017-02-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52128-148
Start Marketing Date : 2012-12-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
A Methylprednisolone Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methylprednisolone Acetate, including repackagers and relabelers. The FDA regulates Methylprednisolone Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methylprednisolone 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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A Methylprednisolone Acetate supplier is an individual or a company that provides Methylprednisolone Acetate active pharmaceutical ingredient (API) or Methylprednisolone Acetate finished formulations upon request. The Methylprednisolone Acetate suppliers may include Methylprednisolone Acetate API manufacturers, exporters, distributors and traders.
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