Drug Approval | July 08, 2022
Lupin’s Somerset manufacturing plant Receives EIR from US FDA
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
Site Enhances New Modality CRDMO Platform Capacity for Customers
The new facility will be delivered through an investment of approximately CHF 500 million and is expected to be completed in 2026
The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.
The investment will enable the company to provide customers with a complete and integrated end-to-end solution
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S
This facility will produce higher efficacy products that enjoy greater acceptance and enhanced profit marginsg
U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi
Bringing next-gen cannabinoid therapeutics to cancer patients
With $120m jointly invested in the newly-formed initiative, and with other strategic investors expected to join, the venture will develop an alternative, plant-based ingredient using biotechnology
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