The US Food and Drug Administration approves Alembic Pharmaceuticals Ltd to produce Pregabalin capsules at its Jarod facility, the company announced today.
According to Alembic Pharmaceuticals, this is the first product approval the company has obtained from the Jarod facility.
Alembic Pharma had filed the application with US regulator under the Prior Approval Supplement category, which allows drugmakers to shift their manufacturing base to the new production facility. The company had approval to make this product at its Panelav facility.
USFDA conducted an inspection at the Jarod facility earlier this month.
Pregabalin capsules are used to treat epilepsy, anxiety, and other indications. The drug is therapeutically equivalent of Lyrica capsules owned by Upjohn.
It has an estimated market size of $244 mln for the year ending Sep, the company said, quoting IQVIA data.
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