Aurobindo Reprimanded By SEBI Over US FDA Warning Disclosure

‘Very Limited And Restricted Information’ Revealed By Indian Firm Deemed ‘Insufficient’

The Securities and Exchange Board of India has warned Aurobindo that it did not disclose sufficient information about a US FDA warning letter that it received in connection with its Unit 1 API facility in Hyderabad early this year.

Securities and Exchange Board of India (SEBI) Logo
The Securities and Exchange Board of India says Aurobindo’s disclosures were not sufficient • Source: Shutterstock

Aurobindo’s disclosures relating to a US Food and Drug Administration warning letter received by the firm early this year have fallen under the spotlight, after the Securities and Exchange Board of India sent the Indian company a warning letter of its own for disclosing only limited and insufficient information about the FDA’s actions.

More from Manufacturing

Zelluna Believes Its TCR Tech Can Unlock Natural Killer Cell Potential

 

While CAR-NKs have pivoted towards autoimmune disease, the Norwegian biotech believes its unique platform can deliver in oncology

What’s Next? Five Things To Look Out For In May

 
• By 

Generics Bulletin previews the most noteworthy and anticipated events for May 2025.

Rage Against The Machine: Generics CEOs Slam Systemic Problems In The US

 
• By 

During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.

As US Launches Pharma Probe, AAM Warns Tariffs ‘Will Only Amplify Problems’

 
• By 

News of a fresh US investigation into the pharma sector has sparked renewed concerns over the impact that US trade tariffs would have on the generics and biosimilars industry. The AAM has responded with a warning over the potential effects on shortages and access, while Medicines for Europe has proposed five key action areas to bolster the sector in Europe.

More from Business

What’s Next? Five Things To Look Out For In May

 
• By 

Generics Bulletin previews the most noteworthy and anticipated events for May 2025.

Sandoz And Henlius Join Forces With $300m Ipilimumab Deal

 
• By 

Sandoz has struck a deal worth up to $301m with Henlius giving it rights to a proposed ipilimumab biosimilar to Yervoy in countries across the world.

Speranza Starts Generics Offshoot In Response To Wider US Pharma Manufacturing Drive

 
• By 

Reflecting increased regulatory pressure and a wider drive towards the reshoring of pharmaceutical manufacturing to the US, Speranza has launched a new generics business called Lotus Therapeutics.