Mumbai, July 24: Ipca Laboratories today said it was voluntarily suspending shipments of drug ingredients from one of its plants in the country, following concerns expressed by the US Food and Drug Administration (FDA).
The mid-sized company said the drug regulator had made certain observations in Form 483 after a recent inspection of its active pharmaceutical ingredient unit in Ratlam, Madhya Pradesh.
Form 483 is issued by the FDA when companies fail to meet some of its norms.
Companies are encouraged to respond to the form in writing with their corrective action plan and implement it expeditiously. If the FDA is not satisfied with the action taken, it may result in an import ban.
“Consequent to this, the company has voluntarily decided to temporarily suspend API shipments from this manufacturing facility to the US markets till this issue is addressed,” Ipca informed the stock exchanges.
It added that the voluntarily stoppage would have an impact on its formulations exports to the US because the formulations manufacturing units at Piparia (Silvassa) and the special economic zone in Indore (Pithampur) use the ingredients from the Ratlam facility.
The announcement led to the Ipca stock crashing more than 13 per cent on the bourses. On the BSE, the scrip ended at Rs 727.65, a drop of 13.06 per cent, or Rs 109.35, from its last close.
Drug major Ranbaxy has inked a licensing pact with Canada’s Cipher Pharmaceuticals Inc to exclusively market its isotretinoin capsules, used to treat acne, in Brazil.
The agreement extends Ranbaxy’s relationship with Cipher, under which it is marketing isotretinoin capsules in the US under the brand Absorica, Ranbaxy Laboratories said in a statement.