Take the pledge to vote

For a better tommorow#AajSawaroApnaKal
  • I agree to receive emails from News18

  • I promise to vote in this year's elections no matter what the odds are.
  • Please check above checkbox.


Thank you for
taking the pledge

Vote responsibly as each vote counts
and makes a diffrence


Issued in public interest by HDFC Life. HDFC Life Insurance Company Limited (Formerly HDFC Standard Life Insurance Company Limited) (“HDFC Life”). CIN: L65110MH2000PLC128245, IRDAI Reg. No. 101 . The name/letters "HDFC" in the name/logo of the company belongs to Housing Development Finance Corporation Limited ("HDFC Limited") and is used by HDFC Life under an agreement entered into with HDFC Limited. ARN EU/04/19/13618
Associate PartnerAssociate Partner
LIVE TV DownloadNews18 App
News18 English
News18 » Business
1-min read

Aurobindo Pharma Drops by 5%, Wockhardt Gains 3.7% on USFDA Action

Aurobindo Pharma shares dropped after it was issued Form 483 with 10 observations which were audited by the US drug regulator between 13 May and 24 May.

Trending Desk

Updated:June 14, 2019, 1:20 PM IST
Aurobindo Pharma Drops by 5%, Wockhardt Gains 3.7% on USFDA Action
Image for representation.

Shares of Aurobindo Pharma Ltd dropped over 5% on Friday after the US Food and Drug Administration (USFDA) pointed out data integrity lapses at the company’s finished dosages plant at Bachupally in Telangana. Meanwhile, shares of Wockhardt jumped as much as 3.7% after the company’s bioequivalence center in Maharashtra successfully cleared inspection by the US health regulator.

The US FDA issued Form 483 with 10 observations to Aurobindo Pharma on the plant which was audited by the US drug regulator between 13 May and 24 May.

FDA said laboratory records at the plant do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.

“Specifically, there is no adequate data integrity programme in place to include an adequate review of all electronic raw data by the quality unit to ensure completeness, consistency, and accuracy of all chromatographic raw data generated by the quality control laboratory,” FDA said as one of the observation.

Meanwhile, Wockhardt on Thursday said it has received zero observations from the US Food and Drug Administration (FDA) after inspection of its bioequivalence center at Aurangabad. The USFDA carried out the inspection on 10 and 12 June, the company said.

During the inspection, bioanalytical and quality systems of bioequivalence studies of Tamsulosin 0.4 mg capsules and Metoprolol ER tablets were audited, Wockhardt said. “At the end of inspection, there was zero 483 observations, signifying that best practices were followed, in compliance to regulations,” Wockhardt said.

This outcome would lead to approvals of ANDAs (abbreviated new drug applications) in pipeline, for which bioequivalence studies are being done or will be done at the said centre, added Wockhardt. ANDA refers to a written request to the US FDA to manufacture and market a generic drug in the US.

Get the best of News18 delivered to your inbox - subscribe to News18 Daybreak. Follow News18.com on Twitter, Instagram, Facebook, Telegram, TikTok and on YouTube, and stay in the know with what's happening in the world around you – in real time.

Read full article
Next Story
Next Story

Also Watch

Most Active
Company Price Change %Gain
Infosys 653.70 1.58
Yes Bank 51.75 -0.10
Axis Bank 721.90 1.28
RBL Bank 247.35 -13.80
Indiabulls Hsg 215.75 -1.03
Company Price Change %Gain
Infosys 653.85 1.64
Yes Bank 51.75 -0.10
IRCTC 892.00 5.52
Indiabulls Hsg 215.50 -1.24
RBL Bank 247.35 -13.79
Top Gainers
Company Price Change %Gain
HCL Tech 1,096.00 2.96
Bajaj Finserv 8,212.50 2.54
Eicher Motors 20,477.85 2.50
Titan Company 1,359.65 2.27
SBI 276.05 2.05
Company Price Change %Gain
HCL Tech 1,096.25 2.99
SBI 276.00 2.05
Infosys 653.85 1.64
Maruti Suzuki 7,342.50 1.22
Axis Bank 722.10 1.32
Top Losers
Company Price Change %Gain
Adani Ports 399.80 -4.98
Zee Entertain 245.35 -2.04
IndusInd Bank 1,323.65 -1.29
Grasim 748.00 -1.06
ONGC 142.90 -0.94
Company Price Change %Gain
IndusInd Bank 1,323.50 -1.28
ONGC 142.95 -0.83
Kotak Mahindra 1,615.05 -0.85
HUL 2,110.05 -0.82
Larsen 1,431.00 -0.76

Live TV

Countdown To Elections Results
To Assembly Elections 2018 Results