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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.
Also Read: Sun Pharma Gets SEC Nod to Begin Phase III Trial of Cough Drug Gefapixant
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751