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

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01 7Active
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01 1218MF10539
02 1218MF10825
03 1222MF10158
04 1304MF10098
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01 13923/25
02 1WC-0161
03 1WC-0161A2
04 1WC-0161n
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01 120210626-211-J-1002
02 120250805-211-J-1989
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01 122552-0005
02 124002-0011
03 138779-0004
04 146439-8711
05 151927-1160
06 152128-162
07 153183-0456
08 160722-3018
09 165089-0031
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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-01
Pay. Date : 2014-04-29
DMF Number : 22062
Submission : 2008-10-07
Status : Active
Type : II
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0161
Address of the Firm :
NDC Package Code : 22552-0005
Start Marketing Date : 2017-12-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
Certificate Number : R1-CEP 2008-215 - Rev 00
Issue Date : 2015-06-26
Type : Chemical
Substance Number : 811
Status : Valid
Date of Issue : 2025-05-20
Valid Till : 2028-05-22
Written Confirmation Number : 3923/25
Address of the Firm :
NDC Package Code : 52128-162
Start Marketing Date : 2011-11-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-08-14
Pay. Date : 2018-07-09
DMF Number : 12749
Submission : 1997-11-18
Status : Active
Type : II
Certificate Number : R1-CEP 2002-078 - Rev 03
Issue Date : 2021-03-22
Type : Chemical
Substance Number : 811
Status : Valid
Registration Number : 304MF10098
Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy
Initial Date of Registration : 2022-07-06
Latest Date of Registration :
NDC Package Code : 46439-8711
Start Marketing Date : 1989-05-31
End Marketing Date : 2026-12-31
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.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-29
Pay. Date : 2014-05-21
DMF Number : 4118
Submission : 1981-04-09
Status : Active
Type : II
Certificate Number : CEP 2003-095 - Rev 05
Issue Date : 2025-02-26
Type : Chemical
Substance Number : 811
Status : Valid
| Available Reg Filing : ASMF |
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
Cerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
Certificate Number : R1-CEP 2003-022 - Rev 02
Issue Date : 2021-08-24
Type : Chemical
Substance Number : 811
Status : Valid
Registration Number : 222MF10158
Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain
Initial Date of Registration : 2010-05-24
Latest Date of Registration :
NDC Package Code : 65089-0031
Start Marketing Date : 1985-06-27
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
| Available Reg Filing : RU |
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