Marksans Pharma arm New York facility gets 1 USFDA observation
Mumbai: Marksans Pharma has announced that the US Food and Drug Administration (USFDA) has concluded an inspection with one inspectional observation at the New York manufacturing facility of the Company's wholly owned subsidiary Time-Cap Laboratories, Inc.
The inspection was held from 16th April 2025 to 24th April 2025.
"A current Good Manufacturing Practices (cGMP) inspection was conducted by the USFDA at the manufacturing facility of the Company’s wholly owned subsidiary Time-Cap Laboratories, Inc. located at 7, Michael Avenue, Farmingdale, New York, USA (“the Subsidiary”) from 16th April 2025 to 24th April 2025," the Company stated in a BSE filing.
"On conclusion of the inspection, the Subsidiary has received One (1) inspectional observation in Form 483," Marksans stated.
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An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant.
"There is no data integrity observation. The Subsidiary will work closely with the USFDA and is committed to address the observation comprehensively within the stipulated time," the Company added.
Marksans Pharma Ltd. headquartered in Mumbai, India is engaged in the Research, Manufacturing & Marketing of generic pharmaceutical formulations in the global markets. The company's manufacturing facilities are approved by several leading regulatory agencies including USFDA, UKMHRA, and Australian TGA. The company's product portfolio spreads over major therapeutic segments of CVS, CNS, Antidiabetic, Pain Management, Gastroenterological, and Anti-allergies. The company is marketing these products globally.
