Archive · 1 Dec 2025
Lupin Gets USFDA Nod for Armlupeg Biosimilar
Lupin, a big medicine company, just got permission from the US government to sell a new medicine called Armlupeg.
This medicine helps people who are getting treated for cancer.
It's made in a special factory in Pune, India.
The company's boss, Vinita Gupta, is happy because they plan to make more medicines like this to help more people.
The medicine is expected to sell a lot in the US.
Lupin's stock price went up a little bit after this news.
Lupin received USFDA approval for Armlupeg, a biosimilar to Neulasta.
Armlupeg is intended to reduce infection in cancer patients receiving chemotherapy.
The product will be manufactured at Lupin's Pune facility, which underwent USFDA inspection.
Estimated annual sales for similar products in the US are $1,295 million.
Lupin plans to expand its biosimilar portfolio in the coming years.
- Who
- Lupin, a pharmaceutical company
- What
- Received USFDA approval for Armlupeg, a biosimilar to Neulasta
- When
- Approval announced on Monday
- Where
- Manufactured at Lupin's Pune facility, intended for the US market
- Why
- To decrease infection incidence in cancer patients and improve care quality
- Company
- Lupin
- Approval
- USFDA
- Product
- Armlupeg (pegfilgrastim-unne) 6 mg/0.6 ml injection
- Manufacturing Location
- Pune, India
- Indication
- Decrease infection incidence in cancer patients
- CEO
- Vinita Gupta
