This is a story about a company that is simultaneously an asset and an anomaly. An asset because it builds a tangible, necessary product, g...

UPS Flight 2976 Louisville crash new CCTV footage reveals final moments before aircraft engine catches fire after investigators released su...

As global markets prioritise quality and regulatory trust, India’s pharma sector is recalibrating beyond its traditional cost advantage.

Indian travellers planning trips to Bali and Indonesia can now utilize the Visa on Arrival facility. This allows for short stays of up to 3...

AIESL, a state-owned MRO provider, is expanding its Nagpur facility. The company seeks to serve more international airlines and is pursuing...

The Department for Promotion of Industry and Internal Trade is ensuring continuous supply of fuel, gas, and essential raw materials. Measur...

A new Creditor-initiated Insolvency Resolution Process (CIIRP) aims to expedite debt resolution, allowing financial creditors with 51% debt...

Torrent Pharmaceuticals announced that the US Food and Drug Administration (USFDA) issued a Form 483 with five observations after inspectin...

This follows the abbreviated quality system inspection technique drug pre-approval on-site inspection specifically conducted by the US Food...

"There is no data integrity observation. This pre-Approval Inspection is part of the routine business operations and the company shall subm...

Commenting on the audit, GPI Executive Director Priyanka Chigurupati said, "We are glad to have completed yet another audit with minor obse...

The United States Food and Drug Administration (USFDA) had conducted pre-approval inspection at the company's drug formulations facility in...

Biocon on Monday said that pre-approval inspection of the Bengaluru facility of its arm conducted by US health regulator was concluded with...

US health regulator issued six observations in Form 483 after pre-approval inspection of its insulin drug substance manufacturing facility ...

The USFDA inspection at Halol in 2015 had resulted in 23 observations – a set of deficiencies in the manufacturing processes.

The re-inspection will be to verify implementation of the proposed corrective and preventive actions, the company said.

Biocon, with its partner Mylan, will work with the French and European regulatory authorities with regard to the follow- up inspection of t...