Caplin Point Laboratories rose 2.35% to Rs 507.45 after the company said its subsidiary received US drug regulator's approval for etomidate injection USP.
The drug maker said that its subsidiary, Caplin Steriles, received final approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) etomidate injection USP, 20 mg/10 ml (2 mg/ml) and 40 mg/20 ml (2 mg/ml) single-dose vial presentations. The product is generic therapeutic equivalent to Amidate (etomidate) injection, of Hospira Inc.
According to IQVIA (IMS Health), etomidate injection USP had US sales data of approximately $9 million for the 12- month period ending Oct 2020.
Etomidate is a general anesthetic, used for the induction of general anesthesia and for the supplementation of sub potent anesthetic agents.
C. C. Paarthipan, chairman of Caplin Point Laboratories, commented: "We understand Etomidate injection has frequently been on the shortage list in the US, which is probably the reason why we received this approval within 6 months. We hope to launch this product within a short period in the US."
Caplin Steriles has developed and filed 19 ANDAs on its own and with partners, with 11 approvals so far.
The company is also working on a portfolio of 35 simple and complex injectable and ophthalmic products, to be filed over the next 4 years, with an addressable market size of $2.1 billion.
Caplin Point Laboratories is a pharmaceutical company. It holds over 2800 product licenses across the globe, with a dominant position in Latin America. The company is entering into Regulated markets of US, EU, Brazil, Mexico, Australia, with a state of the art manufacturing facility for Injectables, already approved by EU-GMP, ANVISA and US FDA.
The pharmaceutical company reported 9.7% increase in consolidated net profit to Rs 62.83 crore on 18% increase in revenue from operations to Rs 268.12 crore in Q2 FY21 over Q2 FY20.
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