Glenmark, Granules shares gain after USFDA developments; check details here

Glenmark, Granules shares gain after USFDA developments; check details here


Shares of Glenmark Pharmaceuticals Ltd. and Granules India Ltd. traded higher on Monday, July 6, after both drugmakers announced key developments in the US market.

Glenmark Pharmaceuticals

Glenmark Pharmaceuticals said it has launched Olanzapine for Injection (10 mg/vial) in the US, expanding its injectables portfolio.

The product is the generic equivalent of Zyprexa IntraMuscular Injection and is indicated for the treatment and long-term maintenance of schizophrenia.

According to IQVIA data, the reference product recorded annual sales of approximately $25.4 million in the 12 months ended May 2026.

Marc Kikuchi, President and Business Head, North America, said the launch aligns with Glenmark’s strategy to strengthen its injectables portfolio and expand its presence in the institutional healthcare segment while improving access to affordable medicines.

Granules India

Granules India announced that it has secured sole first-to-file (FTF) status from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Sodium Oxybate Extended-Release for Oral Suspension, the generic version of LUMRYZ.

The designation marks Granules’ second sole first-to-file approval, following its earlier success with the generic version of Dyanavel XR, and further strengthens the company’s presence in the complex generics segment.

LUMRYZ is approved in the US for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy.

Chairman and Managing Director Krishna Prasad Chigurupati said the milestone reflects the company’s growing research, development and regulatory capabilities and supports its strategy of building a differentiated portfolio of complex generic medicines for regulated markets.



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