Indian Pharmaceutical Company Faces Heat From Health Regulatory Authorities In The US
Inspection by the US Food and Drug Administration found shortcomings in the quality management systems and facility management procedures of Aurobindo Pharma.
Inspection by the US Food and Drug Administration found shortcomings in the quality management systems and facility management procedures of Aurobindo Pharma.
Aurobindo now has 13 ANDAs (represented by 10 product classes) approved out of Unit IV formulation facility in Hyderabad for manufacturing general injectable products and will be marketed and sold by Aurobindo's wholly-owned subsidiary AuroMedics Pharma LLC. The Aurobindo counter closed 0.41 percent up at Rs 738 on the BSE.
US Regulatory Authorities Approve New Drug To Treat Patients With High Cholesterol
The new cholesterol-lowering drug is approved only for adults. It is injectable, and offers an alternative to popular pill-based statins.
The new cholesterol-lowering drug is approved only for adults. It is injectable, and offers an alternative to popular pill-based statins.
Regulatory Authorities In The US Ban Drug Imports From Emcure Pharmaceuticals Ltd, India
The US Food and Drug Administration has barred imports from Emcure's Hinjewadi plant after an inspection showed manufacturing quality standards not met.
The US Food and Drug Administration has barred imports from Emcure's Hinjewadi plant after an inspection showed manufacturing quality standards not met.
Pivotal Expansion: Lupin Pharmaceuticals Acquires US-Based Gavis for $880 Million
In a pivotal move to expand their global presence, an Indian Pharmaceutical company- Lupin Pharmaceuticals, acquired Gavis, a US- based privately- held company.
In a pivotal move to expand their global presence, an Indian Pharmaceutical company- Lupin Pharmaceuticals, acquired Gavis, a US- based privately- held company.
