Biocon says FDA 483 at Malaysian plant not due to non-compliance

By Dan Stanton contact

- Last updated on GMT

GettyImages/LorenzoT81
GettyImages/LorenzoT81

Related tags: Food and drug administration

A US FDA pre-approval inspection of Biocon’s insulin manufacturing facility in Malaysia has resulted in a Form 483 with six observations.

“The US FDA has completed a pre-approval inspection of our manufacturing facility in Malaysia and issued a Form 483 with 6 observations,”​ a Biocon spokesperson wrote in a letter filed with the Bombay Stock Exchange this morning.

“As per the normal expectations of the agency, we intend to respond with a corrective and preventive action plan in a timely manner.”

In-Pharmatechnologist reached out to the Bangalore, India-based company for further details:

“These observations are suggested procedural improvements and not related to non-compliance and as such do not have any material impact,”​ we were told.

The facility, located at the Bio-XCell biotechnology park in Johor, Malaysia, makes insulin active pharmaceutical ingredient (API), insulin analogues and finished products.

Biocon began constructing the facility in 2011​ to produce insulin for Pfizer under a 2010 contract, and commercial operations commenced in 2017.

Among the commercial products made at the plant is Biocon’s rh-insulin, Malaysia’s first locally made biosimilar insulin to be approved by the National Pharmaceutical Regulatory Authority (NPRA). The facility also makes the firm’s insulin glargine brand, Basalog – a biosimilar to Sanofi’s Lantus – for a number of markets.

Last April​, an inspection by Ireland’s Health Products Regulatory Authority (HPRA) resulted in the facility receiving a European GMP certificate dated September 6 2017. The certificate can be found below.

The news is the latest regulatory issue to hit Biocon. A facility in Bangalore – which also makes biosimilars – was criticised by European and US regulators last year​.

   GMP Biocon by Dan Stanton on Scribd

Related news

Related products

show more

Strategies to Achieve Successful Approval & Launch

Strategies to Achieve Successful Approval & Launch

Catalent Pharma Solutions | 03-Sep-2020 | Data Sheet

There are several key considerations to how companies should approach commercial-scale manufacturing that may aid the success of their biologic’s launch...

Single-Pass Tangential Flow Filtration

Single-Pass Tangential Flow Filtration

BioContinuum™ Platform - MilliporeSigma | 01-Aug-2020 | Application Note

Tangential flow filtration (TFF) is widely used in the biopharmaceutical industry for downstream processing applications. Typical TFF steps concentrate...

Related suppliers

Follow us

Products

View more

Webinars