Enforcement Report - Week of August 8, 2018
Claris Injectables On Health Canada Inspection List
Claris Injectables Limited Receives FDA Warning Letter
Enforcement Report - Week of December 27, 2017
Claris Lifesciences was down 3% to Rs 352, falling 6% from its early morning high of Rs 374 on the BSE on Thursday, after the board of directors of the company approved the delisting proposal received from the promoter Athanas Enterprise Pvt Ltd. The stock ended 1% lower at Rs 362 on Wednesday.
US FDA Issues Form 483 to Claris Injectables Ltd.
Harmonisation of drug regulatory framework amongst African countries will help avoid duplication of inspection of Indian manufacturing plants by officials of these countries in Africa leading to an increase in drug cost and delay in drug supply. Recognition of Indian Pharmacopoeia (IP) in African countries will ease the business opportunities for the manufacturers. IP has been built and developed to meet the latest global standards. It is being reviewed and continuously updated incorporating the latest proven changes, said Raghuveer Kini, executive director, Pharmexcil.
Baxter International, which picked up three plants in its just-completed buyout of Claris Injectables, said it intends to start investing in the facilities to expand capacity and add new capabilities.
“Claris Lifesciences Limited (CLL) along with its wholly owned subsidiary Claris Injectables Limited (CIL) announced today that it underwent a successful USFDA Pharmacovigilance (PV) audit from Monday 29th May to Wednesday 31st May with No Observation (i483s). The announcement was made during market hours today, 31 May 2017,” the company said in a statement.
Ahmedabad-based pharmaceutical company Claris Lifesciences Ltd has agreed to sell its entire 20% stake in a joint venture with Otsuka Pharmaceutical Factory Inc. to the Japanese partner. The deal value is $20 million (Rs 128 crore).