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Pharmaceuticals
New Launch23 Oct 2023, 06:17 pm

Aurobindo Pharma Limited Receives USFDA Approval for Testosterone Cypionate Injection

AI Summary

Aurobindo Pharma Limited, a leading integrated global pharmaceutical company, 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.,

Key Highlights

  • Received final approval from USFDA for Testosterone Cypionate Injection
  • Expected launch in November 2023
  • Estimated market size of USS 226.8 million for the twelve months ending August 2023
  • 169th ANDA approval (including 9 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities
AUROPHARMA
Pharmaceuticals
AUROBINDO PHARMA LTD.

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