What is Sitagliptin and Metformin Hydrochloride?

It's a combination medication used to treat type 2 diabetes. Sitagliptin helps your body produce more insulin, while metformin helps your body use insulin more effectively.

How does this approval benefit patients?

Generic medications, like the one approved for Lupin, are often more affordable than brand-name drugs. This can make treatment more accessible for patients.

Where will the medication be manufactured?

Lupin will manufacture the generic drug at its facility in Pithampur, India.

USFDA approval granted for Sitagliptin and Metformin Hydrochloride Tablets

This USFDA approval paves the way for Lupin to market a generic equivalent of Merck Sharp & Dohme's popular brand-name drug, Janumet.

The Health Master

November 29, 2024

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Last Updated on November 29, 2024 by The Health Master

USFDA approval

Lupin Limited, a leading global pharmaceutical company, has achieved a significant milestone by securing tentative United States Food and Drug Administration approval (USFDA approval) for its Abbreviated New Drug Application (ANDA) for Sitagliptin and Metformin Hydrochloride Tablets.

This USFDA approval paves the way for Lupin to market a generic equivalent of Merck Sharp & Dohme’s popular brand-name drug, Janumet.

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A Win for Diabetes Patients

The newly approved generic medication will be available in two strengths: 50 mg/500 mg and 50 mg/1000 mg.

It is designed to help adults with type 2 diabetes mellitus improve their glycemic control when used in conjunction with diet and exercise.

Manufacturing Hub in India

Lupin plans to manufacture this crucial medication at its state-of-the-art facility in Pithampur, India.

This strategic move underscores India’s growing prominence as a global pharmaceutical manufacturing hub.

A Lucrative Market

The US market for Sitagliptin and Metformin Hydrochloride Tablets, 50 mg/500 mg and 50 mg/1000 mg, is substantial, with an estimated annual sales value of $1.145 billion (IQVIA MAT September 2024).

Lupin’s generic entry into this market is expected to significantly benefit patients by offering a more affordable treatment option.

Key Points

Lupin received tentative USFDA approval for generic Janumet.
The generic drug will be available in two strengths.
It will be manufactured in India.
The US market for this drug is substantial.

By securing this USFDA approval, Lupin has demonstrated its commitment to providing affordable and high-quality medications to patients worldwide.

This achievement further solidifies the company’s position as a global pharmaceutical leader.

Also read following FAQs

What is Sitagliptin and Metformin Hydrochloride?

It’s a combination medication used to treat type 2 diabetes. Sitagliptin helps your body produce more insulin, while metformin helps your body use insulin more effectively.
How does this approval benefit patients?

Generic medications, like the one approved for Lupin, are often more affordable than brand-name drugs. This can make treatment more accessible for patients.
Where will the medication be manufactured?

Lupin will manufacture the generic drug at its facility in Pithampur, India.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.