USFDA seeks additional data in Biocon's application for Insulin-R

The reply letter included a statement that a corrective and preventive action plan for the pre-approval inspection of Biocon's facilities in Bengaluru was expected to be satisfactorily implemented

FPJ Web DeskUpdated: Saturday, January 07, 2023, 04:37 PM IST
article-image
USFDA seeks additional data in Biocon's application for Insulin-R | Image: Biocon (Representative)

The US Food and Drug Administration (USFDA) has issued a complete response letter to Biocon Ltd seeking additional data in the company's licence application for the Insulin-R product, the pharma company said in an exchange filing today.

The reply letter included a statement that a corrective and preventive action plan for the pre-approval inspection of Biocon's facilities in Bengaluru was expected to be satisfactorily implemented.

After evaluating Biocon's seven manufacturing facilities spread over two sites in Bengaluru and one site in Malaysia, the federal agency issued Form 483 with numerous observations in August.

In these facilities, the company produces biosimilar medications such Bevacizumab, rh-Insulin, and Insulin Aspart.

According to the company's filing, Biocon is currently working to respond fully to the US Food and Drug Administration's response letter.

(If you have a story in and around Mumbai, you have our ears, be a citizen journalist and send us your story here. )

(To receive our E-paper on WhatsApp daily, please click here.  To receive it on Telegram, please click here. We permit sharing of the paper's PDF on WhatsApp and other social media platforms.)

RECENT STORIES

Mumbai-based GTL named in FIR by CBI over Rs 4,700 cr bank fraud

Mumbai-based GTL named in FIR by CBI over Rs 4,700 cr bank fraud

Pakistani rupee crashes 9.6% to all-time low of 255.4 against US dollar after devaluation

Pakistani rupee crashes 9.6% to all-time low of 255.4 against US dollar after devaluation

Crisis-hit Pakistan turns to US for help with unlocking IMF loans

Crisis-hit Pakistan turns to US for help with unlocking IMF loans

Like Maruti Suzuki, SUV demand doubles Hyundai's profits in Q4

Like Maruti Suzuki, SUV demand doubles Hyundai's profits in Q4

Tech layoffs: SAP may fire 3,000 people after dip in software licensing revenue

Tech layoffs: SAP may fire 3,000 people after dip in software licensing revenue