The shares of Chennai-based Pharmaceutical stock surged as much as 5.7% today after its subsidiary company received its final approval from the USFDA for its Procainamide Hydrochloride Injection.
Share Price Movement
The shares of Caplin Point Lab Ltd, with a market capitalization of Rs 16,722 Crores, closed at Rs 2,199 per share 4.4% higher than its previous close of Rs 2,107. The shares generated a return of 57% in 1 year, 172% in 3 years, and an impressive 703% in 5 years respectively.
What Happened
As per a press release dated February 5,2025, the U.S. Food and Drug Administration has granted its final approval to the subsidiary company of Caplin Point Lab Ltd called Caplin Steriles Ltd.
Caplin Steriles Ltd got its approval from the USFDA for its Abbreviated New Drug Application (ANDA) Procainamide Hydrochloride Injection USP, 1g/10mL and 1g/2mL Vials, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) PRONESTYL, from Apothecon Inc.
Procainamide hydrochloride Injection is an antiarrhythmic medicine used to treat certain arrhythmia i.e. abnormal heart rhythm. It restores normal heart rhythm by blocking abnormal electrical signals in the heart.
According to IQVIA (IMS Health), Procainamide hydrochloride Injection had US sales of approximately $20 million for the 12-month period ending December 2024.
Recent Updates
As per a press release dated January 17, 2025, Caplin Steriles Limited has been granted final approval from USFDA for its Levetiracetam in Sodium Chloride Injection, 500mg/100mL, 1000mg/100mL and 1500mg/100mL infusion bags, a generic therapeutic equivalent version of the Reference Listed Drug, from HQ Speciality Pharma Corp.
Financials
The company reported an increase of 18% in Revenue from Operations from Rs 410 Crores in Q2FY24 to Rs 483 Crores in Q2FY25. Its Net Profits grew by 13% from Rs 116 Crores to Rs 131 Crores during the same period.
India Pharma Industry
The Indian Pharmaceutical industry is presently ranked third in pharmaceutical production by volume after evolving over time into a thriving industry growing at a CAGR of 9.43% since the past nine years. India has the highest number of pharmaceutical manufacturing facilities that comply with the USFDA and has 500 API producers that make for around 8% of the worldwide API market.
About Caplin Steriles Ltd
Caplin Steriles Limited is a sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA. It has developed and filed 46 ANDAs in the USA on its own and with partners, with 33 approvals so far.
About Caplin Point Lab Ltd
The company was established in 1990 to manufacture a range of ointments, creams and other external applications. Its main research and development facilities are located in Tamil Nadu and has a manufacturing plant in Puducherry, India. It has over 4000 product licenses across the globe with over 650+ pharmaceutical formulations & over 36 therapeutic sections.
Written By Adhvaitha Nayani
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