5 replies to this topic

[mtelander]

We have some customers looking to break into the "Peptides" market. Specifically they are looking at 2 - Methylene Blue and Pinealon. I am having a hard time finding any concrete directive on our ability to use those peptides to manufacture "dietary supplements". Would there be some misbranding risk involved if they are pharmaceutical grade only? Has anyone worked with these types of materials?

 

*We are a dietary supplement contract manufacturer - so our customers own the formulas but we source the ingredients for that formula and then manufacture the finished good

[TimG]

I have no direct experience with peptides. What are you basing "pharmaceutical grade" on? Is there a USP monograph and will be you ensuring it meets standards of that monograph?

Edit: I do have experience with Pharma grade excipient ingredients.

Edited by TimG, Yesterday, 04:37 PM.

[mtelander]

The pharmaceutical grade comment was just based on what i have seen other companies market it as, we havent even started the sourcing process yet because i want to make sure its a material we can work with as a dietary supplement co-man. Other websites that are selling "Methylene Blue" are saying its pharmaceutical grade so im concerned that they dont make a "food grade" that we could use

[TimG]

The pharmaceutical grade comment was just based on what i have seen other companies market it as, we havent even started the sourcing process yet because i want to make sure its a material we can work with as a dietary supplement co-man. Other websites that are selling "Methylene Blue" are saying its pharmaceutical grade so im concerned that they dont make a "food grade" that we could use

Ahh, so if I'm understanding you want to be sure you can use 'pharma grade' in your food grade? 

[mtelander]

Yup, my biggest concern is ending up getting flagged for "misbranding" because the peptide itself isnt considered a "dietary ingredient"

[TimG]

Customer owns the formula and does the branding? I believe that puts the onus of misbranding on them. Do they have requirements on how/what you source for their formulas?

I never dealt with supplements/vitamins specifically; however, I know my USP grade product WAS used in a vitamin in one of our customers products and they chose to go with our higher grade over our GRAS food grade version.