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Results For "Caplin-Point-Laboratories-Limited"

18 News Found

Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution
Drug Approval | February 27, 2025

Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure


Briefs: Caplin Point Laboratories, Hikal and Cipla
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


Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags
Drug Approval | January 18, 2025

Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags

This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles


Caplin Point receives EIR from FDA with Zero 483 observations
Drug Approval | January 07, 2025

Caplin Point receives EIR from FDA with Zero 483 observations

The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.


Caplin Steriles gets USFDA approval for Difluprednate Ophthalmic emulsion
Drug Approval | December 17, 2024

Caplin Steriles gets USFDA approval for Difluprednate Ophthalmic emulsion

Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery


Caplin Point announces completion of unannounced USFDA inspection
Drug Approval | August 11, 2024

Caplin Point announces completion of unannounced USFDA inspection

The inspection was concluded with zero observations


Caplin Steriles gets USFDA approval for Ephedrine Sulfate injection USP
Drug Approval | July 23, 2024

Caplin Steriles gets USFDA approval for Ephedrine Sulfate injection USP

Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension


Caplin Point gets Colombia approval for Softgel Capsules
Drug Approval | May 07, 2024

Caplin Point gets Colombia approval for Softgel Capsules

The Unit currently caters to emerging markets of Latin America and Africa with a variety of dosage forms


Caplin Steriles gets USFDA approval for Ofloxacin ophthalmic solution
Drug Approval | April 17, 2024

Caplin Steriles gets USFDA approval for Ofloxacin ophthalmic solution

Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers


Caplin Group commences operations of Rs. 150 crore oncology facility
News | March 28, 2024

Caplin Group commences operations of Rs. 150 crore oncology facility

The facility will manufacture tablets, capsules, and injections for the oncology segment