Mylan Laboratories Gets CDSCO Nod to Manufacture and Market Epinephrine tartrate Injection

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-10-26T17:45:00+05:30 | Updated On 26 Oct 2024 5:45 PM IST

New Delhi: Mylan Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Epinephrine tartrate Injection IP 0.3mg/0.3ml & 0.15mg/0.3ml (Auto injector) (Adrenaline Injection IP).

This came after the firm presented their proposal for a grant of permission to manufacture and market Epinephrine tartrate Injection IP 0.3mg/0.3ml and 0.15mg/0.3ml (Auto-injector) along with justification for bioequivalence (BE) waiver and clinical trial waiver.

Epinephrine is a hormone and neurotransmitter used to treat allergic reactions, to restore cardiac rhythm, and to control mucosal congestion, glaucoma, and asthma.Epinephrine injection is indicated in the emergency treatment of type I allergic reactions, including anaphylaxis. It is also used to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

The firm has informed that Epinephrine tartrate Injection IP 0.3mg/0.3ml & 0.15mg/0.3ml (Auto injector) is already approved in USA.

At the recent SEC meeting for pulmonary held on 3rd October 2024, the expert panel reviewed the proposal for the grant of permission to manufacture and marketing of Epinephrine tartrate Injection IP 0.3mg/0.3ml & 0.15mg/0.3ml (Auto injector) along with justification for BE waiver and clinical trial waiver.

After detailed deliberation, the committee recommended the grant of permission for manufacturing and marketing of Epinephrine tartrate Injection IP 0.3mg/0.3ml & 0.15mg/0.3ml (Auto-injector) with different color coding for each applied strength.

Also Read: Bisoprolol, Telmisartan, Chlorthalidone FDC: CDSCO asks Windlas Biotech to submit new BE protocol

mylan labscdscoadrenalineEpinephrine auto-injectors

Dr. Divya Colin

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

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