Panacea Biotec Pharma Baddi facility gets 9 USFDA observations
Punjab: Panacea Biotec Limited has announced that the Company’s material wholly-owned subsidiary, Panacea Biotec Pharma Limited (“PBPL”) has received nine observations from the United States Food and Drug Administration (USFDA) for the Baddi facility at the end of the inspection.
The inspection was held between October 03, 2023 and October 12, 2023.
"At the end of the inspection, PBPL was issued an ‘FDA Form 483’ with nine (9) observations which are related to improvements in existing procedures and are addressable. PBPL will respond to the US FDA within the stipulated time and work closely with US FDA to close the said observations," Panacea informed in a BSE filing.
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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.
"We are committed to patient safety and quality and take quality and compliance matters seriously and stand by our commitment to fully comply with the cGMP quality standards," the Company added.
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Panacea Biotec was set up in the year 1984, under the name of Panacea Drugs Private Limited. It got publically listed on Indian National Stock Exchanges in September 1995 as Panacea Biotec Ltd. The international pharmaceutical formulations product portfolio includes innovative prescription products in niche therapeutic areas such as Pain, Diabetes & Cardiovascular management, Oncology, Renal Disease, Osteoporosis management and Gastro-intestinal care.
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