Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 1Gonane Pharma
03 1ASG Biochem
04 2Fujifilm Diosynth Biotechnologies
05 1Pfizer Inc
06 1Steroid SpA
07 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 1China
02 3India
03 1Italy
04 1U.S.A
05 2United Kingdom
01 1Active
02 2Inactive
03 5Blank
01 1Withdrawn by Holder
02 7Blank
01 8Blank
01 8Blank
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Status : Withdrawn by Holder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
NDC Package Code : 49803-007
Start Marketing Date : 2019-01-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25000g/25000g)
Marketing Category : BULK INGREDIENT
A Estradiol Cypionate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estradiol Cypionate, including repackagers and relabelers. The FDA regulates Estradiol Cypionate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estradiol Cypionate 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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