Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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01 10009-0026
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10 152128-149
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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 : 2022-06-30
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 : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.
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 : 65089-0017
Start Marketing Date : 2005-02-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
Date of Issue : 2025-05-20
Valid Till : 2028-05-22
Written Confirmation Number : 3923/25
Address of the Firm :
NDC Package Code : 52128-148
Start Marketing Date : 2012-12-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
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 : 2026-12-31
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 : 2026-12-31
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 : Reviewed
Rev. Date : 2025-10-01
Pay. Date : 2025-09-29
DMF Number : 3452
Submission : 1979-02-08
Status : Active
Type : II
Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
NDC Package Code : 10695-041
Start Marketing Date : 2017-08-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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