Friday, October 22, 2021

Pharma company Panacea Biotec gets warning letter from USFDA for Baddi facility


New Delhi: Drug firm Panacea Biotec on Wednesday said it has received a warning letter from the US health regulator for its pharmaceutical formulation facility at Baddi in Himachal Pradesh.

The facility is owned by the company’s wholly-owned unlisted subsidiary Panacea Biotec Pharma Ltd (PBPL), the company said in a BSE filing.

“The company/ PBPL has taken multiple steps after the inspection of the facility conducted during February 10 to 20, 2020 to address the observations received from USFDA during the inspection,” it added.

The company will actively engage with the agency and take all necessary steps required to address the United States Food and Drug Administration (USFDA) concerns, Panacea Biotec said.

Panacea Biotec/PBPL is also in the process of providing a thorough and comprehensive response to the USFDA within the statutory time permitted in the letter, it added.

The warning letter does not materially affect the existing business of the company/PBPL in the US and the existing product supplies from the said pharmaceutical formulations facility will continue, the filing noted.

The USFDA may, however, withhold approval of any new drug applications or supplements till PBPL addresses all issues raised by the agency, the filing said.

“We are committed to patient safety, quality and take all quality and compliance matters seriously and stand by our commitment to fully comply with the cGMP quality standards,” it added.

In the warning letter written to Panacea Biotec MD Rajesh Jain, the US health regulator has flagged that during the inspection of the facility, its investigators observed specific violations, including failure by the firm “to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labelling, and drug products conform to appropriate standards of identity, strength, quality, and purity”.

The warning letter also mentioned that the company failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.





Source link

Latest Articles

Widely used chemical linked to 1,00,000 US deaths per year: Study

NEW YORK: Daily exposure to phthalates, a group of chemicals used in everything from plastic containers to makeup, may lead to approximately 100,000 deaths...

Foods to Reduce Inflammation and Strengthen the Immune System

Did you know that you can greatly reduce inflammation and boost your immune system by simply incorporating more anti-inflammatory foods and beverages into your...

Personal Selling

INTRODUCTION Early sellers and traders were not held in high esteem. The Roman word for salesman meant ‘Cheater’ and...

Building Muscle on a Vegan Diet

There are a lot of  misconceptions surrounding veganism. The notion that those who practice it are lacking in protein and therefore muscles is the...

Electrodes in brain new hope for severe cases of epilepsy

Neurosurgeons at All India Institute of Medical Sciences have devised a new technique for operating on children suffering from a severe form of epilepsy...