Cadila Healthcare Ltd (Zydus Cadila), on Friday, announced that the Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk) has granted marketing approval to commercialise Lipaglyn (Saroglitazar Magnesium) in Mexico.

Lipaglyn is for the treatment of Dyslipidemia in patients with diabetes mellitus Type 2 and Hypertriglyceridemia in patients with diabetes mellitus Type 2 not controlled by statins.

“Saroglitazar is an important scientific and medical breakthrough in our effort to develop medicines for patients suffering from hypertriglyceridemia and diabetic dyslipidemia,” Pankaj Patel, Chairman, Zydus Group, said in a statement here, adding, “This approval of Saroglitazar in Mexico is a major milestone for the company.”

Saroglitazar (Lipaglny) is a novel PPARα/γ agonist having predominant PPAR alpha activity. The recommended dose of Lipaglyn is 4 mg once-a-day. Lipaglyn is a prescription drug and should be taken under the guidance of a registered medical practitioner.

Lipaglyn was first launched in India in September 2013. Over the years, more than 500,000 patients have been treated with Lipaglyn in India, and data has been presented at several scientific and medical conferences, he said.

Elevated triglycerides and insulin resistance are two key components of the metabolic syndrome, which medical science believes are responsible for diseases like hypertriglyceridemia, diabetic dyslipidemia or non-alcoholic steatohepatitis disease (NASH).

Increased triglyceride accumulation in the liver can also lead to inflammation, fibrosis, cirrhosis and liver failure, a serious medical condition known as NAFLD or NASH.

Additionally, Zydus is currently evaluating Saroglitazar in several clinical trials for treating liver conditions like NASH and primary biliary cholangitis (PBC).

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