Granules India announces ANDA approval for Colchicine Capsules, drug has annual US sales of $55 million
Upstox
2 min read • Updated: April 30, 2024, 3:18 PM
Summary
Granules India said Colchicine Capsules are indicated for prophylaxis of gout flares in adults. The drug is bio-equivalent and therapeutically equivalent to the reference listed drug (RLD), Mitigare Capsules, 0.6 mg of Hikma International Pharmaceuticals, the company stated.
Granules India announced on Tuesday that the United States Food and Drug Administration (USFDA) has approved its abbreviated new drug application (ANDA), filed by Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of the company, for Colchicine Capsules, 0.6 mg.
Shares of the company were trading over 1% higher on Tuesday.
Colchicine Capsules are indicated for prophylaxis of gout flares in adults. The drug is bio-equivalent and therapeutically equivalent to the reference listed drug (RLD), Mitigare Capsules, 0.6 mg of Hikma International Pharmaceuticals, the company stated. The current annual US market for Colchicine Capsules stands at approximately $55 million, it said.
Granules now has a total of 64 ANDA approvals from the USFDA.
The company had recently notified the stock exchanges stating that its Unit V facility located at Anakapally in Visakhapatnam, Andhra Pradesh underwent an inspection by the USFDA from April 8 to April 12 with the audit resulting in zero 483s. The audit was a pre-approval inspection (PAI) and current good manufacturing practices (cGMP) audit for active pharmaceutical ingredients (APIs) and formulations, the company said.
During the third quarter of fiscal year 2024, Granules reported revenue from operations at ₹1,155.6 crore, registering a growth of 1% year-over-year (y-o-y) and a decline of 3% quarter-over-quarter (q-o-q). Earnings before interest, tax, depreciation, and amortisation (EBITDA) grew 8% y-o-y to ₹250.50 crore while the EBITDA margin improved to 22% from 20% a year ago. Net profit during the quarter grew 1% y-o-y to ₹125.7 crore. Granules had said its net debt stood at ₹928.5 crore.
API, Pharmaceutical Formulation Intermediates (PFI), and finished dosages contributed 19%, 15%, and 66% of revenue from operations respectively for Q3FY24, the company said. The focus on formulations sales has increased resulting in the momentum shifting from API and PFI to formulations, it added.
Shares of the company have gained over 3% since the beginning of the year. The stock has risen nearly 42% in the last one year.