Cipla Secures CDSCO Panel Nod to Manufacture Amantadine Oral Solution with Trial Waiver
New Delhi: Drug major Cipla has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml with bioequivalence study and clinical trial study waiver.
This came after the firm presented their proposal for the manufacturing and marketing of Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml along with justification for waiver of clinical trial and bioequivalence study before the committee.
The committee noted that Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml is classified as a BCS Class I drug and has been approved in the United States since 28.10.1994 for the treatment of Parkinsonism.
Amantadine is in a class of medications called adamantanes. It is thought to work to control movement problems by increasing the amount of dopamine in certain parts of the body. It works against influenza A virus by stopping the spread of the virus in the body.
Amantadine is used to treat the symptoms of Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) and other similar conditions. It is also used to control movement problems that are a side effect of certain medications used to treat Parkinson's disease.
Amantadine extended-release capsules are used along with the combination of levodopa and carbidopa to treat ''off'' episodes (times of difficulty moving, walking, and speaking that may happen when other medications wear off) in people with Parkinson's disease. It is also used to prevent symptoms of influenza A virus infection and for treatment of respiratory infections caused by influenza A virus.
At the recent SEC meeting for Neurology and Psychiatry held on 24th June 2025, the expert panel reviewed the proposal for the manufacturing and marketing of Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml along with justification for waiver of clinical trial and bioequivalence study before the committee.
After detailed deliberation, the committee recommended for grant of permission to manufacture and market Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml with bioequivalence study and clinical trial study waiver.
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