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       #Post#: 6149--------------------------------------------------
       Eugia gets USFDA Approval Testosterone
       By: Road2HardCoreIron Date: May 30, 2025, 10:24 am
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       Eugia Pharma receives USFDA Approval for Testosterone Cypionate
       Injection USP 1,000 mg/10 mL (100 mg/mL) and 2,000 mg/10 mL (200
       mg/mL) in Multi-Dose Vial and 200 mg/mL in Single-Dose Vial
       PUBLISHED : OCTOBER 24, 2023
       Ref: Aurobindo Pharma
       Aurobindo Pharma Limited is pleased to announce that its wholly
       owned subsidiary company, Eugia Pharma Specialities Limited, has
       received final approval from the US Food & Drug Administration
       (USFDA) to manufacture and market Testosterone Cypionate
       Injection USP 1,000 mg/10 mL (100 mg/mL) and 2,000 mg/10 mL (200
       mg/mL) in Multi-Dose Vial and 200 mg/mL in Single-Dose Vial,
       which is bioequivalent and therapeutically equivalent to the
       reference listed drug (RLD), Depo-Testosterone Injection, 100
       mg/mL and 200 mg/mL of Pfizer Inc. The product is expected to be
       launched in November 2023. The approved product has an estimated
       market size of US$ 226.8 million for the twelve months ending
       August 2023, according to IQVIA.
       This is the 169th ANDA approval (including 9 tentative approvals
       received) out of Eugia Pharma Speciality Group (EPSG)
       facilities, manufacturing both oral and sterile specialty
       products.
       Testosterone Cypionate Injection USP is indicated replacement
       therapy in the male in conditions associated with symptoms of
       deficiency or absence of endogenous testosterone, Primary
       hypogonadism (congenital or acquired) and Hypogonadotropic
       hypogonadism (congenital or acquired).
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