Granules India Ltd Share Price – NSE  / BSE

Pharmaceuticals, Small Cap

Granules India announced today that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), has received approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lisdexamfetamine Dimesylate Chewable Tablets. The approved drug is available in multiple strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg.

This generic drug product has been determined to be bioequivalent (AB Rating) to the reference listed drug, Vyvanse® Chewable Tablets by Takeda Pharmaceuticals USA Inc. Lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients aged six years and older, as well as Moderate to Severe Binge Eating Disorder (BED) in adults.

Granules has received approval in the first review cycle, reflecting the company's consistent focus on regulatory excellence and expedited product delivery. Lisdexamfetamine Dimesylate Chewable Tablets are currently published on the FDA Drug Shortages List, emphasizing their critical role in patient care.

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The approved drug is available in multiple strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg.

This generic drug product has been determined to be bioequivalent (AB Rating) to the reference listed drug, Vyvanse chewable tablets by Takeda Pharmaceuticals USA Inc.

Lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged six years and older, as well as moderate to severe binge eating disorder (BED) in adults.

The approved drug is currently published on the FDA drug shortages list, emphasizing their critical role in patient care.

Dr Krishna Prasad Chigurupati, chairman & managing director of Granules, said, This milestone reflects our unwavering commitment to addressing unmet patient needs by delivering high-quality, affordable medications. With this approval, GPI reinforces its dedication to alleviating critical drug shortages in the U.S. healthcare market.

Granules India now holds 68 ANDA approvals, including 30 ANDAs from GPI.

Granules India is primarily involved in the manufacturing and selling of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs).

Granules India consolidated net profit fell 4.79% to Rs 97.23 crore on 18.74% decline in total revenue from operations to Rs 966.62 crore in Q2 FY25 over Q2 FY24.

The scrip rose 0.13% to currently trade at Rs 585.10 on the BSE.

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Granules India Ltd is up for a fifth straight session in a row. The stock is quoting at Rs 580.3, up 0.03% on the day as on 12:44 IST on the NSE. The benchmark NIFTY is down around 0.26% on the day, quoting at 24554.85. The Sensex is at 81341.22, down 0.21%. Granules India Ltd has added around 1.4% in last one month.

Meanwhile, Nifty Pharma index of which Granules India Ltd is a constituent, has added around 0.49% in last one month and is currently quoting at 22309.1, down 0.33% on the day. The volume in the stock stood at 6.31 lakh shares today, compared to the daily average of 37.56 lakh shares in last one month.

The benchmark December futures contract for the stock is quoting at Rs 580.65, down 0.07% on the day. Granules India Ltd is up 50.59% in last one year as compared to a 16.94% gain in NIFTY and a 38.62% gain in the Nifty Pharma index.

The PE of the stock is 37.46 based on TTM earnings ending September 24.

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The United States Food and Drug Administration (USFDA) has further classified the inspection as ‘Official Action Indicated’ (OAI).

The drug maker has responded to all the observations issued by the USFDA. Additionally, it has voluntarily undertaken a comprehensive evaluation of the facility for further enhancements that lead to improvement of the facility.

“The company will work with the US FDA on this activity and is confident that it will result in the US FDA approving the company’s facility at Gagillapur in compliance with its expectations within a short time,” Granules stated in a regulatory filing.

Granules India is primarily involved in the manufacturing and selling of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs).

Granules India consolidated net profit fell 4.79% to Rs 97.23 crore on 18.74% decline in total revenue from operations to Rs 966.62 crore in Q2 FY25 over Q2 FY24.

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