Propublica has a new search tool to determine any manufacturer issues that are not made public by FDA.
Heads up:
Here is the link to the manufacturer of Dr. Reddy’s sirolimus 1mg, in case anyone uses that product. Interpret as you wish.
5 Likes
Good find! Here are the Zydus sirolimus reports. I don’t see any show-stoppers, in a Quick Look.
5 Likes
I’ve always been using Pfizer’s brand-name drug, generic versions generally have some issues with their absorption curves.
2 Likes
I’m not sure how to interpret any of this if I’m being honest. I use Dr. Reddy’s 1mg…
1 Like
I do find this odd:
“There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.”
“Scientifically sound laboratory controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials conform to appropriate standards of identity, strength, quality and purity.”
These seem like elementary steps in any manufacturing process. I think this tarnishes the reputation of Zydus.
I worked for a company that manufactured small production runs of specialized equipment for 3-letter agencies. Zydus’s lack of written procedures is mind-boggling to me.
4 Likes
Neither here nor there, but FWIW, I took both Zydus and Biocon for prolonged periods and Biocon at the same 6mg dose and protocol (empty stomach) tested after 48 hours was consistently higher in the serum (5.6 ng/mL Biocon Eris vs 4.4 Zydus).
6 Likes
Is there any independent lab that has published results of testing most of the sources for sirolimus?