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Drug Approval | February 10, 2025
Briefs: Caplin Point Laboratories, Hikal and Cipla
Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
EPS climbs to Rs 9.25 for the quarter
Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy
Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K
Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure
This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles
The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery
He has been associated with Caplin Steriles Ltd., Mylan Laboratories Ltd., Caplin Point Laboratories Ltd., Strides Arcolab Ltd. and Novartis Vaccines and Diagnostics
The inspection was concluded with zero observations
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