Saroglitazar

Name: Saroglitazar in Primary biliary cholangitis: Generic, brand name and therapeutic class of product
Published: 2026-09-14T15:39:06-04:00

Primary biliary cholangitis

Manufacturer: Zydus Therapeutics
Regulatory submission: NDA submitted by May 2026
Launch: Anticipated in April 2027, the start of Zydus fiscal year 2028
Last updated: September 19, 2026

Section

Product information and disease description Product description Product information

Generic, brand name and therapeutic class of product

3 evidence topics · 3 sources

Product and sponsor

Field	Quoted record
Generic name	“saroglitazar magnesium”
Sponsor	“Zydus Therapeutics Inc.”

Manufacturer: Zydus Therapeutics

“Zydus Therapeutics’ New Drug Application (NDA) for Saroglitazar to treat Primary Biliary Cholangitis (PBC) granted Priority Review by the US FDA” (opens the source at this quote in a new tab)

Manufacturer relationship

“As a subsidiary of Zydus Lifesciences, we have access to strong research, development and manufacturing capabilities.” (opens the source at this quote in a new tab)

U.S. brand name

No evidence found.