Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
02 1Gonane Pharma
03 1AASraw Biochemical Technology Co., Ltd
04 1ASG Biochem
05 1Fareva
06 1Naari
07 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 2China
02 4India
03 1Luxembourg
01 1Active
02 6Blank
01 1Valid
02 6Blank
01 7Blank
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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 : 23836
Submission : 2010-05-18
Status : Active
Type : II
Certificate Number : R1-CEP 2012-144 - Rev 01
Issue Date : 2023-07-11
Type : Chemical
Substance Number : 139
Status : Valid
NDC Package Code : 24823-901
Start Marketing Date : 2011-10-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Estradiol Benzoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estradiol Benzoate, including repackagers and relabelers. The FDA regulates Estradiol Benzoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estradiol Benzoate 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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