USFDA approves for marketing of Pirfenidone tablets

Pirfenidone tablet is used to treat lung disease in America

USFDA has approved for the marketing of Pirfenidone tablets to treat lung diseases in America.
USFDA has approved for the marketing of Pirfenidone tablets to treat lung diseases in America. Photo credit: Christine Sandu on Unsplash

Alembic Pharmaceuticals stated that the regulator of the US health had allowed the marketing of Pirfenidone tablets used for the treatment of lung disease in the massive market of America. Now, with this approval, Alembic Pharma is all set to go.

Alembic Pharmaceuticals is an integrated research and development company. It is renowned for manufacturing and marketing generic pharma products across the world. Recently, it said that the US Food and Drug Administration (USFDA) had given its final approval for its ANDA (abbreviated new drug application) for the Pirfenidone tablets – 801 mg and 267 mg (As per the report published in Business Standard). 

It is therapeutically equivalent to Genentech’s RLD (reference listed drug) product, Esbriet Tablets – 801 mg and 267 mg. Pirfenidone tablets are used to treat IPF (idiopathic pulmonary fibrosis).

The approvals from ANDA

For this particular ANDA, Alembic Pharmaceuticals had gotten tentative approval previously. It was in the list of first ANDA applicants that submitted a complete ANDA having a paragraph IV certification, as per the drug manufacturer.

The case with Genetech has been settled by Alembic Pharmaceutical, and the company is all set to launch its generic medicine according to the settlement’s terms. 

The company holds a total of 167 ANDA approvals (23 tentative approvals and 144 final approvals) from the USFDA.

What is IPF?

Idiopathic pulmonary fibrosis or IPF is a lung condition when the lungs become scarred and lead to breathing problems. It mostly affects people between 70 and 75 years of age and is rarely found in people under 50 years of age. Pirfenidone tablets are used for treating IPF.

In the era of Covid-19, breathing problem is something that should not be neglected, and treatment must be done instantly.

Alembic Pharmaceuticals reports for the market size and fall

As per reports published in The Economic Times, Pirfenidone tablets (801 mg and 267 mg) possess a market size of around US$548 million by the end of 2021. Alembic Pharmaceuticals reported a fall of 39.7% in net profit and has landed at Rs 176.42 crore. 

Also, about 3.2% of net sales have fallen and have landed on Rs 1,271.7 crore in the fourth quarter of the fiscal year 2022. At present, Alembic Pharmaceuticals make about Rs 5000 crore sales. 

Products and services of Alembic Pharma

Alembic Pharmaceuticals is a multinational pharma company based in India and is involved in manufacturing pharma substances, products, and intermediates. In India, the company is known as the market ruler in the macrolides segment of anti-infective drugs. Besides, Alembic Pharma makes and sells pharmaceuticals and APIs (active pharmaceutical ingredients). Also, it offers domestic and international formulations along with generic and branded formulations under its domestic formulations.

The company massively invested its capital in research and development (R&D) in the United States. With the drastic increase in the population and the betterment of demand and supply, things are going to be under control very soon. The current situation looks grim because of the war and the subsequent financial crisis. But with time, everything will be fine.


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