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Latest From Apotex Inc.
Manufacturers Want Delay In Conducting US Nitrosamine Risk Assessments
Perrigo, Pfizer want the US FDA to postpone its March 1 deadline for conducting nitrosamine risk assessments. Generics exec cites“serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.
Torrent Expects Indian Dapagliflozin Ruling In Q3
With the India business on the road to recovery and the US growth outlook muted, Torrent hopes to keep the boat steady in fiscal 2021. It also expects an order in Q3 in a patent infringement case pertaining to AstraZeneca’s Farxiga, where it and multiple Indian firms are seeking to launch generic versions.
Torrent Expects India Ruling On AZ's Farxiga In Q3
With the India business on the road to recovery and the US growth outlook muted, Torrent hopes to keep the boat steady in fiscal 2021. It also expects an order in Q3 in a patent infringement case pertaining to AstraZeneca’s Farxiga, where it and multiple Indian firms are seeking to launch generic versions.
Spike In Drug Recalls Expected As US FDA Resumes Inspections, Targeting COVID-19-Related Problems
Attorneys and recall consultants say any firm distributing products associated with COVID-19 should expect to receive the highest level of scrutiny as the US FDA resumes inspections and uses its enforcement muscle to prohibit companies from making adulterated products, such as hand sanitizers, or making fraudulent claims.
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Molecular Diversity
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- Apobiologix
- ApoPharma, Inc.
- Apotex Australia
- Arrow Pharmaceuticals Pty Ltd.
- Arrow Remedies Private Limited
- Arrotex Australia Group Pty Ltd
- Aveva Drug Delivery Systems, Inc.