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Exclusive | CNBC-TV18 accesses 10 USFDA observations issued to Zydus Life’s Jarod facility
KV Prasad Jun 13, 2022, 06:35 AM IST (Published)
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Summary
Zydus Life Share Price | Last week, Zydus Life had informed the stock exchanges that it had received 10 observations from the USFDA, which had inspected the Jarod facility from April 15 to 23.
CNBC-TV18 has accessed the 10 observations the US Food and Drug Administration (USFDA) issued for Zydus Life’s Jarod facility.
Last week, Zydus Life had informed the stock exchanges that it had received 10 observations from the USFDA, which had inspected the Jarod facility from April 15 to 23.
Following are the 10 observations accessed by CNBC-TV18:
1) Failed to review unexplained discrepancy in batch distribution
2) Establishing sampling plans and test procedures not followed
3) Procedures to prevent contamination didn’t include adequate validation
4) Procedures to prevent microbio contamination not followed
5) Failed to establish procedures to establish purity and quality of products
6) Aseptic processing areas to monitor environmental conditions are deficient
7) Equipment and utensils not cleaned and maintained properly
8) Employees engaged in manufacturing drug product lack the training required
9) Procedures for cleaning and maintenance of equipment are deficient
10) Appropriate controls over computers are not excercised
“The company will closely work with the USFDA to address and respond to the observations in an expeditious manner,” Zydus Life had informed the stock exchanges last week.
On another note, last month, the pharma company said it had launched a tablet for the treatment of overactive bladder — Mirabegron Extended-Release tablets, 25 mg — in the US market.
“Mirabegron is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency,” the company said in a stock exchange filing.
The tablet will be manufactured at the company’s formulation manufacturing facility in Ahmedabad SEZ in India.
Zydus Life shares were trading 1.34% higher at ₹966.35 apiece at 12.30 pm. The stock has gained 67.63% in the past six months and 87.28% in the past year.
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