Friday, August 14, 2020
Home Uncategorized Sun Pharma Gets Warning Letter from USFDA

Sun Pharma Gets Warning Letter from USFDA

New Delhi: Sun Pharmaceutical Industries has received a warning letter from the US drug regulator (USFDA) over violation of manufacturing norms in its facility at Halol in Gujarat on Saturday.

Inspection of the facility in September 2014 by US Food and Drug Administration (USFDA) inspectors is followed by the warning letter.

Before the September 2014 inspection, USFDA has approved the future products from the Halol facility. This might continue until all the issues are resolved.

“Sun Pharma expects to request a re-inspection by USFDA upon completion of its remediation commitments,” the company said.

It further added that it will continue to supply its product to its customers to meet its commitment towards customers and patients.

“Sun Pharma will respond to this Warning Letter with a detailed plan within the stipulated timeframe,” it said.

Sun Pharma Managing Director Dilip Shanghvi commented “While our team is working hard to ensure that the commitments made to the USFDA in September 2014 are fully completed, we will continue to cooperate with the USFDA and undertake any additional steps necessary to ensure that the US agency is completely satisfied with our remediation of the Halol facility.”

“We are pledged to being cGMP compliant and are committed to continuing to supply our customers and patients across the world with quality products that meet all specifications,” He added.

Sun Pharma responded to the USFDA inspection observations with a “robust remediation process that is still ongoing, with significant investments in automation and training to enhance its Quality Systems”.

The company was working with some external consultants to ensure remediation activities completed in an appropriate manner, it added.

Since the inspection of September 2014, the company has communicated regularly with the USFDA on the progress of its remediation and on issues of product supply.(IANS)

STAY CONNECTED

18,953FansLike
362FollowersFollow
1,780FollowersFollow

Most Popular

Young Women More Stressed Than Men During Lockdown: Survey

A recent survey on the impact of the Covid-19 pandemic on people between 10 and 24 years in UP, Bihar and Rajasthan has revealed...

Doctors Estimated 3 Folds Rise in Deaths of Patients During Lockdown Due to “Waitlist Mortality”

By Ashish Srivastava The nationwide lockdown imposed from March 24 has affected services across sectors, and key areas of medical care were also not left...

Sukhwinder Singh Believes Consistency Works Well

Sukhwinder Singh feels that being "slow and steady" is the best way to live. The Bollywood singer, who has lent his voice for an...

Dumping: Threat To Survival Of Domestic Newsprint Industry

Indiscriminate import and dumping of newsprint paper are threatening the very survival of the domestic newsprint industry, says the Indian Newsprint Manufacturers Association (INMA),...

2 in 5 Schools Lacked Access to Basic Handwashing Facilities in 2019 Worldwide: Report

Two in five schools (43 per cent) around the world lacked access to basic handwashing facilities in 2019, a key condition for educational institutes...

Users Overestimate Time Spent on Facebook by 3.2 Hours a Day

Facebook users especially teenagers and young adults significantly overestimate how much time they spend on the social network in a day and underestimate the...

Covid-19 Induced Lockdowns May Escalate Obesity

In an eye-opening study, scientists have warned that locking down society to combat Covid-19 creates psychosocial insecurity that leads to obesity and may escalate...

83% Women Assert Finding Right Match is About Compatibility and Not Compromise: Survey

After 74 years of Independence are women in this country able to choose their own destiny, their life paths or even their own life...

Recent Comments