Shilpa Medicare slips 5% as USFDA issues Form 483 for Telangana facility

Shares of Shilpa Medicare were locked in 5 per cent lower circuit at Rs 489 -- down 9 per cent from intra-day high -- on the BSE on Wednesday after the US health regulator issued Form 483, with 15 observations for the company’s facility in Telangana.

Till 12:11 pm, a combined 217,507 shares had changed hands and there were pending sell orders for 38,590 shares on the BSE and NSE.

“The US Food and Drug Administration (USFDA) conducted Good Manufacturing Practices (GMP) inspection of Shilpa Medicare’s finished dosage formulation facility (sterile and non-sterile) located at S-20 to S-26, Pharmaceutical Formulations SEZ, TSIIC, Jadcherla, Telangana State, India from 13-25, Feb 2020,” the company said in a exchange filing.

At the conclusion of inspection, the agency issued Form 483, with 15 observations, it said.

The company further said it is preparing responses to the observations, which will be submitted to the agency within 15 business days. The company is committed to address these observations promptly, it said.

The pharmaceutical company's stock hit a multi-year high of Rs 539 in early morning deal. The stock price has more than doubled in the past one month, from the level of Rs 260 on January 24, 2020. In comparison, the S&P BSE Sensex slipped 3 per cent during the period.

Shilpa Medicare is a global brand in manufacturing and supplying of affordable active pharmaceutical ingredient (API) and formulation globally in different regulated markets.

For the October-December quarter (Q3FY20), the company had reported more than four-fold jump in its consolidated net profit at Rs 55 crore on the back of strong revenues. It had profit of Rs 11.92 crore in the same quarter last fiscal. Earnings before interest, tax, depreciation, and amortisation (Ebitda) margin expanded by 1550 basis points to 32.1 per cent from 16.6 per cent in Q3FY19.