Important updates from IPCA concall regarding impact of USFDA import alerts â
With latest import alerts, all facilities (Ratlam, pithampur&silvassa) catering to US market are facing import alert from USFDA for violation of GMP. However,USFDA has exempted two products (hydrocholoquine sulphate and propranolol hydrochloride)from silvassa formulation facility. this is in addition to 4 products FDA had exempted from Ratlam API facility. As per the management IPCA has already begun shipment to US, however, there was no updates on market dynamics. Also, management expects all facilities to be USFDA GMP compliant before Dec 2015 - company has installed hardwares required for automation of facility and softwares updates are in progress.
In another major development, EU/ WHO/ TGA Aussie audit at Ratlam has concluded and facility received 9 observations (2 major and 7 minor). Major observations are regarding Quality Management and Labortaory practices.Management is expected to reply to this observations in next 4 weeks and post which management expect the facility to receive clearance within 2 months. Also, post this audit, IPCA has stopped institutional sales to Africa until facility receive clearance â so rev from institutional sales will be NIL in Q4 and maybe for extended period if IPCA doesnât receive WHO clearance.
Athal Formulation facility which account for 90% of euro revenue is due for Audit in current year so EU/WHO inspection can be expected any time. Also, Krebs, Alpha labs facilities are currently not USFDA complaint hence it may take more time to get USFDA approvals.
In all, i guess more pain can be expected in near term especially if companyreceiveimport alert from any other major regulator.