Strides Pharma Science receives FDA approval for Pregabalin capsules

Strides Pharma Science Limited (Strides) has achieved a significant milestone in the pharmaceutical industry with the United States Food & Drug Administration (USFDA) approval of Pregabalin capsules, spanning dosages from 25 mg to 300 mg. This approval was granted to Strides Pharma Global Pte. Limited, Singapore, a step-down wholly owned subsidiary of Strides, marking a pivotal advancement in the treatment of fibromyalgia.

The approved Pregabalin capsules are bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Lyrica capsules, originally marketed by Upjohn US. This equivalence signifies that patients and healthcare providers can expect the same efficacy and safety profile as the original Lyrica capsules, which have been a cornerstone in fibromyalgia management.

Fibromyalgia, a long-term condition characterized by widespread pain, fatigue, and other symptoms, affects millions worldwide. The approval of Strides’ Pregabalin capsules offers a promising alternative for patients, potentially improving accessibility and treatment affordability. The market size for Pregabalin capsules is estimated at approximately US$248 million per IQVIA data, highlighting the significant demand and market opportunity for this medication.

Expanding Treatment Options: Strides Pharma Secures FDA Nod for Fibromyalgia Medication

Strides plans to manufacture the Pregabalin capsules at its state-of-the-art facility in Puducherry, India. This facility’s role in producing the capsules underscores Strides’ capabilities in drug manufacturing and its commitment to meeting global healthcare needs.

The company boasts an impressive portfolio with 260 cumulative Abbreviated New Drug Application (ANDA) filings with the USFDA, including the recently acquired portfolio from Endo at Chestnut Ridge. Of these filings, more than 235 ANDAs have already been approved. Looking forward, Strides has ambitiously set a target to launch approximately 60 new products in the US market over the next three years, demonstrating its strategic focus on expanding its presence and portfolio in one of the world’s largest pharmaceutical markets.

The USFDA approval of Pregabalin capsules by Strides Pharma Science Limited is a testament to the company’s rigorous commitment to quality and patient care in the pharmaceutical sector. This approval not only enhances the treatment landscape for fibromyalgia but also positions Strides as a key player in generic pharmaceuticals, ready to meet the complex challenges of healthcare affordability and accessibility. With its strategic investments in drug development and manufacturing capabilities, Strides is well-positioned to continue its trajectory of growth and innovation, benefiting patients and healthcare systems worldwide.