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

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01 1Symbiotec Pharmalab
02 1Fareva
03 1Minakem
04 1Androst Biotech
05 1Gonane Pharma
06 1ASG Biochem
07 1Ax Pharmaceutical Corporation
08 1Cohesion Biotec
09 1Darmerica
10 1Fagron Group
11 2Fujifilm Diosynth Biotechnologies
12 1Letco Medical
13 1Pfizer Inc
14 1Shakti Lifescience
15 1Steroid SpA
16 1Zhejiang Xianju Pharmaceutical Co. Ltd
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01 1Canada
02 1China
03 1France
04 6India
05 1Italy
06 1Luxembourg
07 1Netherlands
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09 2United Kingdom
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01 1Active
02 2Inactive
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01 1Withdrawn by Holder
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01 1WC-0561
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01 124823-916
02 149803-007
03 151552-1056
04 160592-210
05 160722-3026
06 162991-3212
07 171052-277
08 173377-071
09 173774-003
10 185207-016
11 185745-006
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01 19Blank
NDC Package Code : 24823-916
Start Marketing Date : 2022-06-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Androst Biotech delivering high-quality hormone APIs and intermediates with trusted global compliance and competitive excellence.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5047
Submission : 1983-07-25
Status : Active
Type : II
Certificate Number : R0-CEP 2000-394 - Rev 00
Issue Date : 2001-11-05
Type : TSE
Substance Number :
Status : Withdrawn by Holder

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 : 2992
Submission : 1977-07-12
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 : 3833
Submission : 1980-05-21
Status : Inactive
Type : II

Date of Issue : 2023-06-26
Valid Till : 2023-06-25
Written Confirmation Number : WC-0561
Address of the Firm :
NDC Package Code : 73774-003
Start Marketing Date : 2021-11-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 85745-006
Start Marketing Date : 2025-06-18
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

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We have 16 companies offering Estradiol Cypionate
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