Alembic Pharma gets USFDA OK for Pregabalin capsules from Jarod unit

Alembic Pharma gets USFDA OK for Pregabalin capsules from Jarod unit

Pregabalin capsules are used to treat epilepsy, anxiety, and other indications. The drug is therapeutically equivalent of Lyrica capsules owned by Upjohn

FPJ Web DeskUpdated: Thursday, December 22, 2022, 04:21 PM IST
article-image
Image credit: Wikipedia (Representative)

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.

(To receive our E-paper on WhatsApp daily, please click here.  To receive it on Telegram, please click here. We permit sharing of the paper's PDF on WhatsApp and other social media platforms.)

RECENT STORIES

Fitch flags contagion risk for Adani group firms, cites weak governance

Fitch flags contagion risk for Adani group firms, cites weak governance

Balrampur Chini Mills extinguishes 2,37,624 shares under buyback norms

Balrampur Chini Mills extinguishes 2,37,624 shares under buyback norms

Crisil upgrades DLF's long-term rating to stable from positive

Crisil upgrades DLF's long-term rating to stable from positive

How Mobility Management is Helping MaaS Providers Shape the Future of Transportation

How Mobility Management is Helping MaaS Providers Shape the Future of Transportation

Mukesh Ambani's Reliance controls 70% stake in Sintex after receiving shares worth Rs 600 crore

Mukesh Ambani's Reliance controls 70% stake in Sintex after receiving shares worth Rs 600 crore