The US Food and Drug Administration(USFDA) has issued Form 483 with 9 observations to Aurobindo Pharma Limited's unit 4 in Hyderabad, citing serious deficiencies in maintaining the manufacturing quality standards. The FDA representatives had inspected the facility between February 12-20, 2018.
Located in Pashamailaram industrial estate on the city outskirts, Unit-4 is a dedicated manufacturing facility for generic sterile injectables ( lyophilized and powder injections, prefilled syringes), opthalmics and low volume parenterals. According to the Form 483, a copy of which was ...
TO READ THE FULL STORY, SUBSCRIBE NOW NOW AT JUST Rs
Key stories on business-standard.com are available to premium subscribers only.
Already a premium subscriber? LOGIN NOW
MONTHLY STAR
Business Standard Digital
MONTHLY STAR
Business Standard Digital
Business Standard Digital Monthly Subscription
149.00
subscribe
Complete access to the premium product
Convenient - Pay as you go
Pay using Master/Visa Credit Card & ICICI VISA Debit Card
Auto renewed (subject to your card issuer's permission)
Cancel any time in the future
Requires personal information
What you get?
ON BUSINESS STANDARD DIGITAL
- Unlimited access to all the content on any device through browser or app.
- Exclusive content, features, opinions and comment – hand-picked by our editors, just for you.
- Pick 5 of your favourite companies. Get a daily email with all the news updates on them.
- Track the industry of your choice with a daily newsletter specific to that industry.
- Stay on top of your investments. Track stock prices in your portfolio.
- 18 years of archival data.
NOTE :
- The product is a monthly auto renewal product.
- Cancellation Policy: You can cancel any time in the future without assigning any reasons, but 48 hours prior to your card being charged for renewal. We do not offer any refunds.
- To cancel, communicate from your registered email id and send the email with the cancellation request to assist@bsmail.in. Include your contact number for speedy action. Requests mailed to any other ID will not be acknowledged or actioned upon.
SMART MONTHLY
Business Standard Digital
SMART MONTHLY
Business Standard Digital
Business Standard Digital - 12 Months
1499.00
subscribe
Get 12 months of Business Standard digital access
Single Seamless Sign-up to Business Standard Digital
Convenient - Once a year payment
Pay using an instrument of your choice - Credit/Debit Cards, Net Banking, Payment Wallets accepted
Exclusive Invite to select Business Standard events
What you get
ON BUSINESS STANDARD DIGITAL
- Unlimited access to all content on any device through browser or app.
- Exclusive content, features, opinions and comment - hand-picked by our editors, just for you.
- Pick 5 of your favourite companies. Get a daily email with all the news updates on them.
- Track the industry of your choice with a daily newsletter specific to that industry.
- Stay on top of your investments. Track stock prices in your portfolio.
NOTE :
- This product is a monthly auto renewal product.
- Cancellation Policy: You can cancel any time in the future without assigning any reasons, but 48 hours prior to your card being charged for renewal. We do not offer any refunds.
- To cancel, communicate from your registered email id and send the mail with the request to assist@bsmail.in. Include your contact number for easy reference. Requests mailed to any other ID will not be acknowledged or actioned upon.
RECOMMENDED FOR YOU