Zydus Lifesciences Gets USFDA Observations for API Plant
By Rediff Money Desk, NEWDELHI Dec 22, 2023 17:09
Zydus Lifesciences received six observations from the USFDA after an inspection of its API plant in Ahmedabad. The inspection closed with no data integrity issues or repeat observations.
New Delhi, Dec 22 (PTI) Zydus Lifesciences on Friday said the US health regulator has issued six observations after inspecting its active pharmaceutical ingredient (API) site in Ahmedabad, Gujarat.
The US Food and Drug Administration (USFDA) conducted the inspection from December 14 to December 22, 2023.
The inspection closed with six observations, Zydus Lifesciences said in a regulatory filing.
There were no data integrity related observations, it added.
Besides, there are no repeat observations from the previous inspection, it noted.
There are four drug master files (DMFs) from the site under approval with the USFDA, the drugmaker said.
The company will closely work with the USFDA to address the observations, it added.
The US Food and Drug Administration (USFDA) conducted the inspection from December 14 to December 22, 2023.
The inspection closed with six observations, Zydus Lifesciences said in a regulatory filing.
There were no data integrity related observations, it added.
Besides, there are no repeat observations from the previous inspection, it noted.
There are four drug master files (DMFs) from the site under approval with the USFDA, the drugmaker said.
The company will closely work with the USFDA to address the observations, it added.
Read More On:
DISCLAIMER - This article is from a syndicated feed. The original source is responsible for accuracy, views & content ownership. Views expressed may not reflect those of rediff.com India Limited.
You May Like To Read
TODAY'S MOST TRADED COMPANIES
- Company Name
- Price
- Volume
- IFL Enterprises
- 1.36 (+ 4.62)
- 87758144
- Franklin Industries
- 3.89 (+ 4.29)
- 25996256
- Vodafone Idea L
- 16.03 ( -4.53)
- 19638763
- Indian Renewable
- 256.95 ( -5.62)
- 13585638
- AvanceTechnologies
- 0.91 ( 0.00)
- 10543963
MORE NEWS
ASK Property Fund Invests Rs 190 Cr in...
ASK Property Fund has invested Rs 190 crore in a real estate project being developed by...
Japan Trade Deficit Shrinks as Exports Rebound
Japan's trade deficit narrowed in the first half of 2023, driven by a recovery in...
Asian Paints Shares Drop 4% After Q1 Earnings
Asian Paints shares fell over 4% on Thursday after the company reported a 24.64%...