Glenmark Pharma gains on USFDA nod for tacrolimus capsules

Glenmark Pharmaceuticals rose 1.25% to Rs 480.50 after the company received final approval by the US drug regulator for tacrolimus capsules in multiple strengths.

Tacrolimus capsule USP, 0.5 mg, 1 mg and 5 mg, is the generic version of prograf capsule of Astellas Pharm US, Inc.

According to IQVIA sales data for the 12-month period ending September 2020, the prograf capsules market achieved annual sales of approximately $286.8 million.

Tacrolimus is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney, liver, or heart transplant. This medication belongs to a class of drugs known as immunosuppressants.

Glenmark's current portfolio consists of 166 products authorized for distribution in the U.S. marketplace and 45 ANDA's pending approval with the United States Food & Drug Administration (USFDA).

"In addition to these internal filings, the company continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio," the drug maker said in a filing issued before market hours today.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across generics, specialty and over-the-counter (OTC) business with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.

The drug maker's consolidated net profit slipped 8.4% to Rs 233.99 crore on 5.2% increase in net sales to Rs 2,908.12 crore in Q2 September 2020 over Q2 September 2019.

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