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Caplin Steriles bags USFDA nod for Phenylephrine hydrochloride Ophthalmic Solution
Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% is indicated to dilate the pupil of the eyes.
Chennai: Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% (eye drops).
The product is a generic therapeutic equivalent version of the Reference Listed Drug (RLD), from Alcon Research LLC.
Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% is indicated to dilate the pupil of the eyes.
According to IQVIA (IMS Health), Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% had US sales of approximately $32 million for the 12-month period ending Mar 2024.
Medical Dialogues team had earlier reported that Caplin Steriles had received nod from the USFDA for its Abbreviated New Drug Application (ANDA) Ofloxacin Ophthalmic Solution USP 0.3% (eye drops).
Read also: USFDA grants nod for Caplin Steriles Ofloxacin Ophthalmic Solution
Caplin Steriles Limited is a sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA. Caplin Steriles Limited, has developed and filed 41 ANDAs in USA on its own and with partners, with 28 approvals so far. The Company is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products, that it intends to file over the next 4 years. The company also has multiple products filed with several approvals in non-US markets such as Mexico, Australia, Canada, South Africa etc.
Read also: Caplin Steriles bags USFDA approval for Ketorolac tromethamine Ophthalmic Solution
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
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