REMS has nothing to do with API
REMS - Risk Evaluation and Mitigation Strategy. Only a few drugs are in this category - lenalidomide being one of them.
Lenalidomide is teratogenic - if this drug is taken by a pregnant female, it causes limb anomalies in the child born (phocomelia is the medical term for such limb malformations). Babies are born with very short arms and legs. This happened in 1960s when thalidomide was given to pregnant females as an antinausea drug - babies were born with very short limbs and the drug was banned . It made a comeback in the 1990s in the treatment of myeloma. Lenalidomide is the better version of thalidomide but has the same teratogenic potential.
In view of the above risk, doctors have to educate the patient very well before prescribing/dispensing. Physicians have to mention all the potential side effects including its teratogenic potential. Patients taking this drug should not become pregnant or should not impregnate their partner if male. This has to be documented online - they call it REMS in the USA. This is a legal document which makes it clear the precautions the patient has to follow whilst on this therapy. The patients are not allowed to distribute this drug to other people because of the above risk…
The REMS system used to have the name Revlimid (Celgene’s lenalidomide brand name) on their website - they are changing the name to lenalidomide (chemical name) since there will be several companies in 2022 who are allowed to sell it in the US. Celgene is still in charge of the REMS for lenalidomide - they have to follow up on serious side effects as it occurs as part of the monitoring system of REMS.
Nothing major in my view…
I am pretty sure lenalidomide API is manufactured within the company…