Novel Laboratories Inc.
https://www.lupin.com/
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Latest From Novel Laboratories Inc.
The Quality Lowdown: Wishing Wished-For FDA Re-Inspections Had Gone Better?
As the COVID-19 pandemic wore on, industry clamored for the US FDA to re-inspect troubled drug manufacturing plants remotely if need be to clear them for new approvals. Now FDA investigators are out in force and early returns from Sun, Aurobindo, Lupin and Sterling suggest these re-inspections will be as tough as ever.
Lupin’s Corporate Quality Oversight Questioned In FDA Warning Letter
Two-month inspection during pandemic highlighted cross-contamination risks and process validation shortfalls at New Jersey plant.
Company Information
- Industry
- Distributors
- Services
-
Pharmaceuticals
- Generic Drugs
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Drug Delivery
- Controlled Release
- Topical Delivery
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