Biocon receives EIR from USFDA for good manufacturing practice inspection

"We remain committed to global standards of quality and compliance," company spokesperson said.

Biocon on Friday said it has received the establishment inspection report (EIR) from US health regulator for the post-approval and good manufacturing practice (GMP) inspection of its small molecules manufacturing facility in Bengaluru.

"The EIR has been closed with a voluntary action indicated (VAI) classification for the observations, the company spokesperson said in a filing to BSE.

"Biocon has received the EIR from the US Food and Drug Administration (FDA) for the post-approval and GMP inspection of its small molecules active pharmaceutical ingredient (API) manufacturing facility at 20th KM, Biocon Campus, Bengaluru, conducted between Feb 20 and Feb 26, 2020," as per the filing.

At the conclusion of the inspection last month, the agency had issued a Form 483, with two observations, which were procedural in nature and are being addressed by the company, the filing said.

"We remain committed to global standards of quality and compliance," company spokesperson added.

The shares of Biocon were trading at Rs 257.00 apiece on the BSE, up 1.76 from the previous close.

Amazon looks to disrupt healthcare by entering medical supplies marketplace

Amazon shook up the prescription-drug industry last month with its $1 bn agreement to acquire online pharmacy PillPack Inc.

Amazon.com Inc. has global aspirations for its medical-supplies marketplace, according to a job listing posted on its website, highlighting the e-commerce giant’s sweeping ambitions to disrupt healthcare by selling products to hospitals, doctors and dentists and offering prescription drugs.

The world’s biggest online retailer is looking to hire someone to lead outreach to medical-products manufacturers and service providers, who will focus on building the business in the US and then expanding it globally, according to a new job post. Amazon started the Amazon Business marketplace in 2015, with health care among the industries it listed as potential customers -- along with factories, offices and universities. The new job posting emphasizes that what works for most businesses isn’t working for medical-industry clients.

"Our mission is to make Amazon the preferred shopping destination for healthcare customers," the post states. "Our Healthcare customers have different needs than traditional Amazon Business customers and thus we are reinventing everything from how we display our selection, price our products, and provide the right customer experience. We seek to understand the specific needs of our healthcare customers, vendors, and sellers in order to deliver innovative solutions to serve their needs."

Amazon shook up the prescription-drug industry last month with its $1 billion agreement to acquire online pharmacy PillPack Inc., following a series of deals between insurance companies and drug-benefit managers that aimed to blunt Amazon’s anticipated foray into the $300 billion prescription-drug business.

Amazon Chief Executive Officer Jeff Bezos joined Berkshire Hathaway Inc. CEO Warren Buffett and JPMorgan Chase & Co. CEO Jamie Dimon earlier this year to form a new venture to address rising healthcare costs. The group recently hired surgeon and health journalist Atul Gawande to steer the effort.

Story By BS