Biocon Biologics receives EIR from USFDA for two manufacturing facilities

Image
Capital Market
Last Updated : Apr 16 2020 | 9:50 AM IST
Biocon Biologics, a subsidiary of Biocon, has received the Establishment Inspection Report (EIR) from the U.S. FDA for the Pre-Approval Inspection (PAI) at two of its biologics manufacturing facilities in Bengaluru. The inspection was conducted between 10 September and 19 September 2019. Biocon Biologics has responded to the regulator on the eight observations from this inspection, in the month of October 2019.

Subsequent to the above inspection, Biocon Biologics has received approvals for the two products Trastuzumab (Drug Product) and Pegfilgrastim (Drug Substance) from the U.S. FDA in 2019. The receipt of the Establishment Inspection Report (EIR) indicates a successful closure of the inspection. This is an endorsement of our commitment to global standards of Quality and Compliance.

Powered by Capital Market - Live News

Disclaimer: No Business Standard Journalist was involved in creation of this content

*Subscribe to Business Standard digital and get complimentary access to The New York Times

Smart Quarterly

₹900

3 Months

₹300/Month

SAVE 25%

Smart Essential

₹2,700

1 Year

₹225/Month

SAVE 46%
*Complimentary New York Times access for the 2nd year will be given after 12 months

Super Saver

₹3,900

2 Years

₹162/Month

Subscribe

Renews automatically, cancel anytime

Here’s what’s included in our digital subscription plans

Exclusive premium stories online

  • Over 30 premium stories daily, handpicked by our editors

Complimentary Access to The New York Times

  • News, Games, Cooking, Audio, Wirecutter & The Athletic

Business Standard Epaper

  • Digital replica of our daily newspaper — with options to read, save, and share

Curated Newsletters

  • Insights on markets, finance, politics, tech, and more delivered to your inbox

Market Analysis & Investment Insights

  • In-depth market analysis & insights with access to The Smart Investor

Archives

  • Repository of articles and publications dating back to 1997

Ad-free Reading

  • Uninterrupted reading experience with no advertisements

Seamless Access Across All Devices

  • Access Business Standard across devices — mobile, tablet, or PC, via web or app

More From This Section

First Published: Apr 16 2020 | 9:23 AM IST

Next Story