ANI Pharmaceuticals (ANIP)

[Just the facts maam]

I think I figured out ANIP's MO for Branded drug development. Novitium and Nuray Chemicals R&D work on finding way to improve existing drugs. Obtain generic approval and get patents for new discovery, Then they file sNDA for the improve vesrion of an existing Branded or Generic drug.

Novitium first got approval of a Generic Hydroxychloroquine Sulfate Drug, once approved, they were later able to get approval for Sovuna (Trademarked) by applying for sNDA and showing how it differentiates form the the original. I imagine it is supported by some form of patent protection somewhere,

Novitium has also obtained a patent for a new and improved carglumic acid for which they have patent. I imagine they have SNDA for this one also.

Novitium also has patents for:
- Oral Liquid Composition Of Terazosin
- hydrochlorothiazide

According to the www.pharmacompass.com, I have seen a pattern where SS Pharma owned and founded by Samy make the FDA GDUFA application with API supplied by Nuray Chemicals. Looking

US Manufacturing

Looking at the Patent Centre
Nuray Chemicals has received patents for the following:
- Levoketoconazole
- Tafamidis

They have applied for patents applications for
- Pitolisant Hydrochloride

When looking at at these three drugs SS Pharma has submitted GDUFA fees for these drugs. Hard to believe they don't make to ANIP' s Product portfolio. Where ANIP will then work toward a sNDA . All have competitive advantages making FDA approvals more likely.