Aurobindo Pharma hits 52-week high on FDA clean chit to Telangana unit

The Aurobindo Pharma share price touched a 52-week high of Rs 796.10 on July 26 after the company received zero observations from the US Food and Drug Administration (USFDA) on a review of a facility run by a subsidiary company.

The US drug regulator inspected the Unit I, a formulation manufacturing facility, of Eugia Pharma Specialities, a wholly owned subsidiary of the company, at Koltur Village in Telangana, from July 17 to 26.

The inspection ended with zero observations and a classification of no action indicated (NAI).

On July 25, the subsidiary received the final approval from the USFDA to manufacture and market Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Mozobil Injection, 24 mg/1.2 mL (20 mg/mL) of Genzyme Corporation. The product will be launched next July.

On July 21, the US FDA issued a ‘Form 483’ with three observations for Unit III, a formulation manufacturing facility at Bachupally Village in Telangana after inspection during July 14-21.