Cipla gets 4 observations from US FDA for its three plants in Goa

The US FDA has been issuing Form 483 observations and warning letters to Indian drug makers for failing to meet good manufacturing practice standards laid down by it

Viswanath Pilla
First Published30 Sep 2016
Cipla has over 35 state-of-the-art manufacturing facilities for API and formulations in India. Photo: Mint<br />
Cipla has over 35 state-of-the-art manufacturing facilities for API and formulations in India. Photo: Mint

Hyderabad: Drug maker Cipla Ltd on Friday informed stock exchanges that said it got four observations from US Food and Drug Administration (US FDA) for three of its manufacturing facilities in Goa.

“US FDA recently concluded audit of our three manufacturing facilities at Goa and has issued four observations across these three facilities,” the company said.

The company didn’t specify the nature of the observations.

Cipla said the observations were primarily “procedural in nature” and the company has already responded to these observations.

“We continue to operate our facilities with a high-level of compliance and control,” Cipla said.

Cipla shares which were down by as much as 7% recovered and were trading at Rs583.50 at 2.90% decline at 12.51pm, the benchmark Sensex dropped 0.24% to 27,748.55 points.

US FDA inspected Cipla’s Goa facility last week. Cipla has over 35 state-of-the-art manufacturing facilities for API and formulations in India.

The US drug regulator conveys its concerns on manufacturing practices through Form 483. Companies that receive its observations must respond in writing with a corrective action plan and implement it quickly. If the company fails to meet the regulator’s expectations, a warning letter may be issued.

The US FDA has been issuing Form 483 observations and warning letters to Indian drug makers for failing to meet good manufacturing practice (GMP) standards laid down by it.

Indian generic exports account for roughly a fifth of the $119.1 billion spent on generic drugs in the US in the last calendar year.

Catch all the Industry News, Banking News and Updates on Live Mint. Download The Mint News App to get Daily Market Updates.MoreLess
HomeindustrymanufacturingCipla gets 4 observations from US FDA for its three plants in Goa

Most Active Stocks

Bharat Electronics

306.40
07:54 AM | 1 JUL 2024
0.2 (0.07%)

Tata Steel

173.90
07:54 AM | 1 JUL 2024
-0.1 (-0.06%)

Wipro

531.10
07:54 AM | 1 JUL 2024
16.2 (3.15%)

Indian Oil Corporation

167.40
07:54 AM | 1 JUL 2024
1.8 (1.09%)
More Active Stocks

Market Snapshot

  • Top Gainers
  • Top Losers
  • 52 Week High

Garden Reach Shipbuilders & Engineers

2,302.00
07:50 AM | 1 JUL 2024
202.45 (9.64%)

Home First Finance Company India

1,126.75
07:49 AM | 1 JUL 2024
90.95 (8.78%)

Cholamandalam Financial Holdings

1,575.20
07:50 AM | 1 JUL 2024
124.3 (8.57%)

JSW Infrastructure

353.45
07:49 AM | 1 JUL 2024
25.35 (7.73%)
More from Top Gainers

Recommended For You

    More Recommendations

    Gold Prices

    • 24K
    • 22K
    Bangalore
    73,272.00-862.00
    Chennai
    73,703.000.00
    Delhi
    72,984.00-1,006.00
    Kolkata
    73,200.00-287.00

    Fuel Price

    • Petrol
    • Diesel
    Bangalore
    102.86/L0.00
    Chennai
    100.75/L-0.10
    Kolkata
    104.95/L1.01
    New Delhi
    94.72/L0.00
    OPEN IN APP
    HomeMarketsloanPremiumMint Shorts