Aurobindo Pharma Ltd lifted investor sentiments and the share prices gained of Aurobindo Pharma gained more than 1% in morning trades on Monday, on a day when benchmark indices were trading in red. Aurobindo Pharma in its filing on the exchanges said that United States Food and Drug Administration (US FDA) conducted a Pre-Approval Inspection (PAI) at Unit-I & III, Formulation manufacturing facility, of APL Healthcare Ltd., a wholly owned subsidiary of the Company, situated in the Mahabubnagar District, Telangana,, from November 13 to 17, 2023. The inspection closed with zero observations and a classification of “No Action Indicated" (NAI).
Also read- Oberoi Realty shares surge 5% on foray into Delhi-NCR real estate market The regulatory clearance of manufacturing facilities by the US drug regulator remains crucial for companies as Aurobindo Pharma, that has high dependance on exports to the US. US sales contribute more than half to Aurobindo’s total revenues. The prospects of the Aurobindo Pharma remain strong in the US markets due to a promising pipeline of injectables and other limited competition products.
However regulatory clearances are important for continued exports of the products to the US. Analysts have maintained a positive outlook for Aurobindo. Analysts at Axis Securities in their results review repot had said Aurobindo Pharma has several growth levers in place.
These are Generic injectables, Eugia ($520 Million sales) that could grow by low double-digit growth based on value-added approval. The launch of Trastzumab biosimilars in 2FY24E, The launch of Pen–G injectible in Q1FY25 estimated and One-time opportunity in generic Revlimid in the next 2-3 years. Revlimid generics have already been launched by the. Read more on livemint.com