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Amneal Pharmaceuticals, the New Jersey-based drug maker promoted by NRI entrepreneur brothers Chirag Patel and Chintu Patel, will be making foray into India's domestic formulation market with focus on biologics, complex injectables and specialty drugs.

The NYSE-listed $2 billion drug maker by sales in 2020, said it will be setting up a 150,000 square feet greenfield biologics manufacturing plant in Ahmedabad, Gujarat catering to global markets. In addition it is also developing novel small molecules and biologic drugs out of India. Amneal over the years has invested $350 million on capex in India, currently it has four manufacturing sites producing active pharmaceutical ingredients, oral solids, and injectables.

In an interview to ET, Chirag Patel, Co-Chief Executive Officer of Amneal said that the company would hit the Indian market with its first product addressing the critical care market as early as the first quarter of 2022.

The company plans to launch a branding and awareness campaign in the second half of 2022, and would be introducing more products.

"We will be creating an Amneal brand (in India)," Patel said.

Patel said Amneal strategy in India is aimed at serving the unmet need, and providing high quality products at affordable prices.

"The same products that go to the US (from the company's manufacturing facilities) will come to India's patients at affordable cost; that's a big differentiator," Patel said.

Patel said the company will bring products from its internal portfolio including its top selling specialty medication Rytary used in treatment of Parkinson's - a Central Nervous System (CNS) disorder, but it is open to partnerships with other drug companies to license products at a later stage.

Patel said Amneal would utilise the 80 member commercial team of Puniska Healthcare, which it acquired early this month for rollout of its products in the India market.

Amneal bought Ahmedabad-based injectable drug maker Puniska for Rs 700 crore.

Pricing pressure

Amneal, which made $1.7 billion from generic sales in 2020, said it is diversifying its product basket from generics to complex injectables, different dosage forms, biosimilars and specialty drugs, and is going global to market drugs, to offset the pricing pressure in the US market. The company has tied up with Chinese drug maker Fosun Pharma to launch products in that market. It is also looking at partnership models to enter other geographies like Europe, Africa and Latin America.

Patel said generic drug prices on an average are going down 10%-12% every year in the US, and is forcing companies like Amneal to leave certain molecules.

"Diversification would help us grow and offset tremendous competition we get in the United States, which is very unsustainable by the way," Patel said.

"Every year, it is the only market in the world, ... (that) lowers the (generic drug) prices from the manufacturers because the buying power is so consolidated, and there's so many suppliers and mainly coming from India and they just want to sell their product. So they sell it at a very, very cheap price and these guys (buyers) have figured out how to get the cheapest price," Patel added.

Patel believes that the generics market in the US will have to correct at some point of time, as the costs of manufacturing and regulatory expectations are rising.

Patel said Amneal has cleared over 80 USFDA inspections in the US and India till date, yielding no major observations and no official action indicated (OAI) classifications or warning letters.

"This was possible due to the culture of quality that's built in the company, along with investments in automation and technology," Patel said.

Patel says they take inspiration from his father who was a drug inspector in India back in 60s and 70s.

"He was one of the toughest one. He never took any bribes, he never tolerated any non-sense, just shut down the factory if it was not complying with regulatory standards, he had received death threats. He wanted things to be done in the right way, that culture is ingrained in us," Patel said.