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The USFDA Grants Final Approval to Zydus for its 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg Carbidopa and Levodopa Tablets USP

The United States Food and Drug Administration (USFDA) has given final approval to Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) to produce and market Carbidopa and Levodopa Tablets USP, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg (USRLD: Sinemet Tablets, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg).

Parkinson’s disease or Parkinson-like symptoms are treated with carbidopa and levodopa. (such as shakiness, stiffness, difficulty moving). This medication is also used to treat carbon monoxide overdose, manganese poisoning, and Parkinson symptoms. At the group’s formulation manufacturing facility in SEZ Ahmedabad, the product will be created. (India).

In the United States, sales of Carbidopa and Levodopa Tablets USP, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg totaled USD $75 million annually. (IQVIA MAT Dec. 2022). The group has so far submitted over 440* ANDAs since the filing procedure began in FY 2003–2004, and it now has 359 approvals.

More About Zydus

Zydus is a leading Indian pharmaceutical company that develops, manufactures, and markets a wide range of pharmaceutical products, including formulations, active pharmaceutical ingredients (APIs), and biologic products. The company was founded in 1952 by Mr. Ramanbhai Patel and is headquartered in Ahmedabad, Gujarat, India.

Zydus has a strong presence in India, with a network of over 25,000 healthcare professionals promoting its products across the country. It also has a global presence, with a presence in more than 50 countries around the world.

The company’s product portfolio includes a wide range of therapeutic categories, including anti-infectives, cardiovascular, gastrointestinal, respiratory, and central nervous system drugs, among others. Zydus also has a strong presence in the biologics segment, with a focus on biosimilars.

In recent years, Zydus has been actively expanding its presence through acquisitions and partnerships. In 2019, the company acquired the select brands and manufacturing operations in India from German pharmaceutical company Eris Lifesciences. In 2020, Zydus partnered with the United States-based biopharmaceutical company Takeda to develop and commercialize novel therapies for the treatment of gastrointestinal diseases.

Overall, Zydus is a major player in the Indian pharmaceutical industry, with a strong presence both domestically and globally, and a diverse portfolio of products and capabilities.

More About Zydus Carbidopa and Levodopa Tablets

Carbidopa and Levodopa Tablets are a combination medication used in the treatment of Parkinson’s disease. Levodopa is converted into dopamine in the brain, which is a neurotransmitter that helps control movement. However, levodopa can be broken down in the bloodstream before it reaches the brain, resulting in less effectiveness of the medication. Carbidopa helps prevent the breakdown of levodopa in the bloodstream, allowing more of it to reach the brain and be converted into dopamine.

Carbidopa and levodopa tablets are typically used to relieve symptoms of Parkinson’s disease, such as tremors, stiffness, and difficulty with movement. The medication is available in different strengths and forms, including immediate-release tablets, sustained-release tablets, and orally disintegrating tablets.

It is important to take this medication exactly as prescribed by your doctor. The dose of the medication may need to be adjusted based on your individual response to the medication and other factors. Common side effects of carbidopa and levodopa tablets include nausea, vomiting, dizziness, and headaches. More serious side effects can include hallucinations, confusion, and worsening of Parkinson’s symptoms.

If you experience any side effects while taking carbidopa and levodopa tablets, it is important to talk to your doctor right away. They may recommend adjusting your dose or switching to a different medication.

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