Shilpa Medicare surges on USFDA approval for Busulfan inj
Shilpa Medicare has received USFDA approval for its ANDA, Busulfan injection, 60 mg/10 ml on April 18, 2018. According to IQVIA MAT Q4 2018 data, the US market for Busulfan injection, 60 mg/10 ml is approximately US$32.8 million.
Busulfan injection, 60 mg/10 ml is a generic equivalent of reference listed drug Busulfex injection, 60 mg/10 ml, used in the treatment of patients with chronic myelogenous leukaemia.
The company has also informed that its Pharmaceutical Research & Development Unit situated at Modavalasa, Vizianagaram, Andhra Pradesh region has received USFDA Establishment Inspection Report (EIR) with an intimation of the closure of inspection on April 8, 2019. The said site had undergone inspection by USFDA during February 11-13, 2019. During that inspection, the company was issued with Form 483 with one observation. Based on the follow-up actions, the USFDA determined the inspection classification of the facility as Voluntary Action Initiated (VAI).
On Monday, the stock of Shilpa Medicare opened gap up at Rs. 413.95 per share and surged by 4.3 per cent making intra-day high of Rs. 416 from its previous close of Rs. 398.70.