Subscribe

0

  • Sign in with Email

By clicking the button, I accept the Terms of Use of the service and its Privacy Policy, as well as consent to the processing of personal data.

Don’t have an account? Signup

  • Bookmarks
  • My Profile
  • Log Out
  • NEWS
  • POLICIES
  • MSME OPPORTUNITIES
  • BANKING & FINANCE
  • TECHNOLOGY FOR SMES
  • SECTORS
  • GLOBAL
  • Investment
  • LEGAL
  • KNOWLEDGE QUEST
  • Future Ready Forum 2025
  • Ek Nayi Udaan
  • Future Ready Summit 2024
  • ADVERTISE WITH US
ad_close_btn
  • News
  • Policies
  • Banking & Finance
  • MSME Opportunities
  • Web Stories
  • InFocus
  • Technology For SMEs
  • Sectors
  • Global
  • Fashion

Powered by :

You have successfully subscribed the newsletter.
InFocus Global

FDI Inspects Wockhardt's Manufacturing Facility

author-image
SMEStreet Desk
22 Jul 2016 03:14 IST

Follow Us

New Update
FDA, Wockhardt,

Wockhardt, India's leading pharma company, informed that US Food and Drug Administration has made "observations" in its establishment inspection report for the company's units in Maharashtra.

The FDI report on the manufacturing facilities does not recommend any change in the US Ban for importing from the company. With this report is also got clarified that the ban to United States from this facility will continue. "Receipt of the report does not change our existing status for the units concerned. It does not materially change the status of an import alert for the units concerned for the US market," Wockhardt said.

Reacting to the news, Wockhardt's shares slumped nearly 5 per cent on the bourses. On the BSE, the stock, which had opened marginally higher at Rs 1,077.70, hit a low of Rs 980 - a drop of 5.54 per cent - and thereafter, closed at Rs 991.15, a drop of Rs 46.35, or 4.47 per cent.

Suven Life Scieneces gets FDA inspection report

On the other hand, US FDA has also issued an Establishment Inspection Report for Suven Life Sciences’ facility at Pashamylaram, near Hyderabad. The company had undergone USFDA renewal inspection at the facility that manufactures and supplied active pharmaceutical ingredients (bulk drugs), intermediates and formulations under Current Good Manufacturing Practice (CGMP) in April this year, according to a statement from Suven. Based on the inspection and review thereafter, the regulator had concluded that the inspection is “closed” and on July 15 issued the EIR. Suven so far has filed 19 DMF’s and four ANDA from the facility which is FDA complaint under CGMP and continued after renewal inspection.

FDI Suvan Life Sciences Food and Drug Administration Wockhardt
Subscribe to our Newsletter! Be the first to get exclusive offers and the latest news
logo

Related Articles
Read the Next Article
Latest Stories
Subscribe to our Newsletter! Be the first to get exclusive offers and the latest news

Latest Stories
Latest Stories
    Powered by


    Subscribe to our Newsletter!




    Powered by
    Select Language
    English

    Share this article

    If you liked this article share it with your friends.
    they will thank you later

    Facebook
    Twitter
    Whatsapp

    Copied!