India-based Aurobindo Pharma reportedly received EU GMP approval for its China-based manufacturing plant last week, as reported by The Hindu Times. The site is anticipated to start generating revenues from the end of Q4 of the company’s fiscal year (FY) 2024 or early in Q1 FY 2025.
Manufacturing and Market Strategy in Europe and China
Aurobindo plans to manufacture approximately five products at the plant, initially focusing on European shipments while awaiting market approval for these products in China. According to the public data, Aurobindo currently holds 9 valid drug approvals on the market and is an active participant in China’s volume-based procurement (VBP) tendering process. The company was a successful bidder in Round 9 of the VBP for its generic version of olmesartan medoxomil and amlodipine in fixed dose combination, and also won bids in previous rounds for mirtazapine and pantoprazole. For companies aiming to supply VBP drugs to China’s public health system, ensuring sufficient supply at a low margin is crucial.
Expansion Plans and Contract Manufacturing Services
Aurobindo is also expanding its manufacturing production within India, particularly for peptides and biosimilar drugs, to improve margins and enhance the company’s EBITDA. In October, Aurobindo signed a ‘letter of intent’ with Merck Sharpe & Dohme (MSD, NYSE: MRK), under which the Indian firm will provide contract manufacturing services for the US giant’s innovative biologics, pending the finalization of a full deal by March 2024.- Flcube.com