• Rajasthan

    Cong 99
    BJP 73
    RLM 3
    OTH 24
  • Madhya Pradesh

    Cong 114
    BJP 109
    BSP 2
    OTH 5
  • Chhattisgarh

    Cong 68
    BJP 15
    JCC 7
    OTH 0
  • Telangana

    TRS-AIMIM 95
    TDP-Cong 21
    BJP 1
    OTH 2
  • Mizoram

    MNF 26
    Cong 5
    BJP 1
    OTH 8

* Total Tally Reflects Leads + Wins

USFDA issues warning letter to Cadila Pharmaceuticals

By: | Published: November 12, 2014 6:57 PM

The US Food and Drug Administration has issued a warning letter to Ahmedabad-based Cadila Pharmaceuticals...

USFDA said, inspectors in March had found significant deviations from standard manufacturing practices at Cadila Pharmaceuticals' Ankleshwar plant, which manufactures active pharmaceutical ingredients.USFDA said, inspectors in March had found significant deviations from standard manufacturing practices at Cadila Pharmaceuticals’ Ankleshwar plant. (Reuters)

The US Food and Drug Administration (USFDA) has issued a warning letter to Ahmedabad-based Cadila Pharmaceuticals for violating current good manufacturing practice norms at its Ankleshwar plant in Gujarat.

In a warning letter, USFDA said inspectors in March had found significant deviations from standard manufacturing practices at Cadila Pharmaceuticals’ Ankleshwar plant, which manufactures active pharmaceutical ingredients.

The significant violations included the failure of the company to adequately probe or take corrective action after customer complaints between 2011 and 2012 about unpleasant odours from, and impurities in, certain drug batches sold in the US, the USFDA said.

The company did not have proper controls in place to prevent the unauthorised manipulation of its electronic raw data, it added.

“Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as an API manufacturer,” USFDA said.

In addition, the company’s failure to correct these violations may result in FDA refusing admission of articles manufactured at Cadila Pharmaceuticals’ Ankleshwar plant into the US, it added.

The FDA issued the letter on October 15, and has given the company 15 days to respond.

The company could not be reached for comments over the FDA letter.

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