Glenmark’s generic Malarone gets FDA OK

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Glenmark’s generic Malarone gets FDA OK

By David Salazar - 06/20/2018
Glenmark Pharmaceuticals has received its first Food and Drug Administration approval for its generic Malarone (atovaquone and proguanil hydrochloride tablets). It marks the first approval for a product that will be manufactured at the company’s new manufacturing facility in Monroe, N.C., Glenmark said.

“This approval is an important milestone for our U.S. business, as the Monroe, N.C. site will expand our portfolio by providing the manufacturing foundation for future product approvals,” said Robert Matsuk, president of North America and global API at Glenmark Pharmaceuticals. “Additionally, we are pleased that the investment we’ve made in our site will continue to create new, high-quality jobs in the Monroe community, where we have a commitment to long-term growth and expansion.”

The generic of GlaxoSmithKline’s Malarone is indicated to prevent Plasmodium falciparum malaria and to treat uncomplicated P falciparum malaria. Glenmark’s generic will be available in two dosage strengths — 250 mg atovaquone/100 mg proguanil and 62.5 mg atovaquone and 25 mg proguanil.

The Mumbai, India-based company, whose U.S. operations are headquertered in Mahwah, N.J., said that it’s Monroe, N.C. facility — into which it invested more than $100 million — is its first designed to manufacture various fixed-dose pharmaceutical formulations. Glenmark said it expected the plant to product between 300 million and 400 million tablets and capsules, between 20 million and 25 million vials and prefilled syringes and between 25 and 30 million ampoules for inhaled formulations.

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