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
The inspection was concluded with zero observations
Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension
The Unit currently caters to emerging markets of Latin America and Africa with a variety of dosage forms
Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers
The facility will manufacture tablets, capsules, and injections for the oncology segment
This investment will be made by Caplin Point Laboratories Limited and its subsidiaries - Caplin Steriles Limited and Caplin One Labs Limited
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients
Thiamine Hydrochloride Injection is effective in the treatment of vitamin B1 deficiency (beriberi)
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