Mylan Labs, Natco Pharma look to expand injectable manufacturing, CEOs say
“We just completed an acquisition for our third fixed dose formulation site last month for a solid oral facility near Hyderabad from Glochem Industries, and one more acquisition of a Unichem site is expected to be done by the end of the month,” Dr. Hari Babu, CEO and managing director of Mylan Laboratories Limited, told In-Pharmatechnologist.com.
The smaller acquisitions come a few months after the company purchased injectables specialist Agila, which was owned by Strides Arcolab, for $1.6bn.
“We acquired only one API plant [in the most recent round of acquisitions], but all of these recent acquisitions basically manufacture solid doses and some extended injectables,” Dr. Babu added. None of the sites will added redundancy for Mylan, which now has nine API manufacturing sites in India and three FDF sites, he added.
As far as how the recent US FDA warning letter for Agila might impact Mylan’s purchase of the plant and work there moving forward, Dr. Babu said the company’s sites will be one of Mylan’s “major growth drivers.”
“I think it’s more focused on India recently,” Babu said in terms of the US FDA targeting specific regions. “But tell me one company that has not received a warning letter? Since India has more facilities, the industry is growing, the number of warning letters may be more. But I don’t think that’s a big constraint or will stop future expansions.”
The company also saw two more acquisitions last year – SMS Pharmaceuticals’ injectable manufacturing unit in Visakhapatnam, India for about $33m, and another small injectable site acquisition.
Natco Pharma raising capital for cytotoxic injectable expansions
As Mylan extends its foothold, Natco Pharma has recently seen a $24m investment that has not officially been announced but has been leaked to some Indian media outlets, Rajeev Nannapaneni, CEO of Natco Pharma Limited, told In-Pharmatechnologist.com.
He added that the investment will help the company build capacity for a cytotoxic injectable plant and possibly build a tablet plant for exports.
“It’s a fairly competitive business [for cytotixics] – it’s dominated by APP, Teva has some presence, Sun does very well, and so does Hospira,” he said, acknowledging Hospira’s recent issues and recalls.
A lot of the plants in the US were built years ago. Partly the reason the Indian market does so well here is that our plants are younger. But import alerts and shut downs have been equally bad in the US and India.
In addition, he noted the difference between a minor warning letter for an injectables facility and one for an API plant, saying “a letter for an injectable facility can be quite serious, in terms of the degree of alertness.” Minor infractions in an injectable warning letter could close a plant down, unlike minor infractions for an API plant, for example, he said.
“Essentially what has happened is that all of the big MNCs [multi-national companies] are leaving the business,” of manufacturing, he said.
As far as new markets are concerned, he said Natco is looking to push into Brazil, Venezuela, Singapore and Canada. And as far as a ceiling down the road, or running into patent cliff issues, he said that for oncology drugs, the pipeline is rich.
“Our philosophy has always been to do a more limited number of products with higher value and higher quality value,” Nannapaneni added.
