Amneal enters Indian formulation market to set up new organic plant in Ahmedabad

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

The NYSE-listed drug maker of $ 2 billion by 2020 revenue said it will set up a new 150,000 square foot biologics manufacturing plant in Ahmedabad, Gujarat, intended for global markets. In addition, he is also developing new small molecules and biological drugs from India. Over the years, Amneal has invested $ 350 million in capital spending in India. It currently has four manufacturing sites producing active pharmaceutical ingredients, oral solids and injectables.

In an interview with ET, Chirag Patel, Amneal’s co-managing director, said the company will hit the Indian market with its first product for the critical care market as early as the first quarter of 2022.

The company plans to launch a brand awareness campaign in the second half of 2022 and would launch more products.

“We are going to create an Amneal brand (in India),” Patel said.

Patel said that Amneal’s strategy in India is to address unmet need and provide high quality products at affordable prices.

“The same products that go to the United States (from the company’s manufacturing facilities) will reach Indian patients at an affordable price; that’s a big differentiator,” Patel said.

Patel said the company will bring products from its internal portfolio, including its best-selling specialty drug Rytary used in the treatment of Parkinson’s disease – a disorder of the central nervous system (CNS), but it is open to partnerships with other pharmaceutical companies to license products at a later stage.

Patel said Amneal will use Puniska Healthcare’s 80-member sales team, which it acquired earlier this month, to roll out its products to the Indian market.

Amneal bought Puniska, an Ahmedabad-based injectable drug maker for 700 crore rupees.

Price pressure

Amneal, which achieved $ 1.7 billion in generic sales in 2020, said it is diversifying its product basket from generics to complex injectables, various dosage forms, biosimilars and specialty drugs, and will market drugs to globally, to offset price pressure in the United States market. The company has partnered with Chinese drug maker Fosun Pharma to launch products in this market. He is also studying partnership models to enter other geographic areas such as Europe, Africa and Latin America.

Patel said generic drug prices are dropping an average of 10% to 12% each year in the United States each year and are forcing companies like Amneal to abandon certain molecules.

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

“Every year, it’s the only market in the world, … (which) drives down the prices (of generic drugs) for manufacturers because the purchasing power is so consolidated, and there are so many suppliers and mostly from India and they just want to sell their product, so they sell it for a very, very low price and these guys (buyers) figured out how to get the cheapest price, ”Patel added.

Patel believes the generic market in the United States will need to correct at some point as manufacturing costs and regulatory expectations rise.

Patel said Amneal has authorized more than 80 USFDA inspections in the United States and India to date, having given no major observations and no official classification or warning letter of action indicated (OAI). .

“This was made possible by the culture of quality that is embedded in the company, as well as the investments in automation and technology,” said Patel.

Patel says they are inspired by his father who was a drug inspector in India in the 1960s and 1970s.

“He was one of the toughest. He never took bribes, he never tolerated any nonsense, he just shut the factory down if it didn’t meet regulatory standards, he had received death threats. He wanted things to be done the right way, this culture is ingrained in us, “Patel said.


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