Goa-I unit of Indoco Remedies fails to impress UK drug regulatory

Indoco Remedies received adverse observations from the British drug regulatory for its Goa – Plant I. The plant was inspected in the third week of March 2018.

The manufacturing plant was handed out seven observations which includes three critical and four major ones by the United Kingdom, Medicines & Healthcare Products Regulatory Agency (UK-MHRA). The inspection of the Plant I situated at L -14, Verna Industrial Estate, Goa was conducted from March 14 to 16. The plant engages in the production of solid dosages, liquid orals and external preparations. The company said its committed to resolving the issue within the time stipulated by UK-MHRA.

Earlier, in February Indoco was granted an European GMP certification dated from Regulatory Authority of Hungary for Goa - Plant III manufacturing facility for non-sterile products, also located in Verna Industrial Estate, Goa. This EU GMP certification will enable Indoco to export medicinal products to all European countries and Canada, Australia and New Zealand.

Indoco Remedies reported revenues of Rs. 274.2 crore during the third quarter of FY 2017‐18, as against Rs. 272.2 crores for the same quarter last year. The company’s PAT is at Rs. 22.7 crores as against Rs. 17.6 crores for the same quarter last year.

The stock reacted sharply to this new development in early trade on Wednesday, Indoco Remedies was at Rs. 223.00 per share, down Rs. 20.10 or 8.27 per cent.