Novopharm
Executive Summary
Has first pre-ANDA inspection of its Canadian manufacturing facilities on July 19 and receives approval for clofibrate capsules (Wyeth-Ayerst's Atromid-S) on July 25. The inspection was conducted by Canadian Health Protection Branch officials as well as FDA inspectors, Novopharm said. The company added that the joint inspection signals the expansion of the memorandum of understanding between the two agencies to allow the HPB to conduct preapproval inspections for FDA.