Pharma firm Caplin Point Laboratories Ltd on Wednesday said its arm Caplin Steriles Ltd has received final approval from the US health regulator for its generic milrinone lactate in 5 per cent dextrose injection indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) milrinone lactate in 5 per cent Dextrose Injection of strengths 20 mg/100 mL and 40 mg/200 mL in single-dose infusion bags, Caplin Point Laboratories said in a regulatory filing. The approved injection is a generic therapeutic equivalent version of the reference listed drug PRIMACOR in dextrose 5 per cent, by Sanofi Aventis US LLC, it added. Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure, the company said. Citing IQVIA (IMS Health) data, the company said milrinone lactate in 5 per cent ...
The facility was inspected between August 12 and 16, 2024, the company said.
Stocks to watch on August 19: The promoters of the company have announced that on August 16, 2024, an entity within the Promoter Group acquired 616,615 equity shares of Piramal Enterprises
The surge in the stock price came after the company announced its June quarter of financial year 2025 (Q1FY25) results.
With a healthy order book, company targets 40-50 per cent growth in revenues in FY24.
So far this calendar year (CY23), shares of Caplin Point have declined 0.4 per cent, as against 1 per cent rise in the S&P BSE Sensex
A combined 5.8 million equity shares, representing 7.6 per cent of the total equity of Caplin Point Laboratories, had changed hands on NSE and BSE till 12:56 pm
Ace investor Ashish Kacholia increased stake in Caplin Point from 1.08 per cent as of December 2020 to 1.16 per cent as of March 2021
Verapamil Hydrochloride is a calcium channel blocker used in the treatment of cardiac conditions such as high blood pressure, arrhythmias and angina.
As many as 63 stocks have zoomed over 1,000 per cent during this period
Caplin Steriles said it has developed and filed 11 ANDAs on its own and with partners, with 5 approvals so far
Caplin Point Laboratories said it believes these observations are procedural in nature and corrective
The stock rallied 14% to Rs 430, trading at its highest level since November 16, 2018 on the BSE.
The stock fell 11% to Rs 532 on the BSE in intra-day trade after the company's ebitda margin in March quarter declined by 400bps to 35% from 39% in previous year quarter.
The stock hit a new high of Rs 5784, rallied 41% in past six trading sessions from Rs 406 on May 10
The stock hit a 52-week high of Rs 467 after the company posted 114% growth in profit at Rs 33 cr
The stock hit a record high of Rs 414, rallied 42% in past three trading sessions from Rs 291 on October 18, 2016.