FDA Approved and Developed Products and Dossiers

New Chemical Entities (NCE): NDA products / A billion dollar worldwide Opportunities

First successful small molecule inhibitor / antagonist of Transient Receptor Potential Cation Channel Subfamily V member (TRPV1) and also known as Capsaicin Receptor or Vanilloid inhibitor.

The NCE would be useful for inflammatory and neuropathic pain. Additionally, the blockade may also be effective in Dry Eye Syndrome, Diabetes and Vulvodynia. No addiction as known for Opioids.

SER-014

  • Phase1 oral dosing pK profile supports twice a day regimen for Neuropathic pain. Ready to go to Phase 2. No adverse side effects associated with the earlier known TRPV1 antagonists. Belongs to a novel class of drugs – Highly potent non-opiate analgesic and anti-inflammatory properties. Today industry is looking for a potent non-opiate analgesic and inflammatory drug.

SER-014

  • Already in preclinical for Ocular indications as well.

American Biopharm Business Partners, LLC

SER -224

  •  Preclinical: Irritable Bowel syndrome

SER -334

  • Preclinical: Acute Pancreatitis

PHE – 575

  •  Innovative formulation of SER-014 for other pain indications: Burn pain, Arthritic pain, Dry eye and other Ocular pain, Uveal Melanoma, rare ocular cancer pain. More active than Gabapentin.

NDA 505 (b2) Product/ Opportunities:

Vancomycin Liquid Injectable : 505 (b2) NDA
Vancomycin Liquid: 24 months refrigerated Lab stability completed.
IND accepted, no new clinical studies required.
Ivacaftor: Oral Solution:
(Current product: Tablet & Granule) - 15 mg/mL
(IND : No additional clinical studies required - US FDA).

Injectable Approved NDA /ANDA for Divestment. (No supplies). Product has to be manufactured by the Buyer at an Alternate site. Alternate site, identified in Europe.

Argatroban (NDA) - 50mg/ 50 mL infusion
Medroxyprogesterone, Suspension -150mg/vial

Product Developed for Europe:

Docetaxel Inj without Polysorbate (Available only for Europe)
(To avoid reactions due to Polysorbate)

Oral US FDA Approved ANDAs for Divestment. ANDA would be transferred to the Buyer's name. Buyer has to transfer manufacturing to another site

Amlodipine + Valsartan tablets - 5 mg + 160 mg, 5 mg + 320 mg
10 mg + 320 mg, 10mg + 320 mg
Levofloxacin tablets - 250mg, 500 mg, and 750 mg
Olanzapine tablets - 5 mg, 10 mg, 15 mg, and 20 mg
Orphenadrine ER tablets - 100 mg
Phentermine Hcl capsules - 15 mg, 30 mg
Phentermine Hcl tablets - 37.5 mg
Zolpidem Tartrate tablets - 5 mg, 10 mg
Zeleplon tablets - 5 mg, 10 mg

Oral US FDA approved products for Out-Licensing (semi- exclusive) with supplies from the Seller

Solifenacin tablets - 5mg, 10 mg
Tadafil Brown tablets - 20 mg
Quinapril Hctz - 10/12.5 mg, 20/12.5 mg
Quinapril tablets - 5 mg, 10 mg, 20 mg, 40 mg
Lamotrigine Tablets - 25 mg, 100 mg, 150 mg, 200 mg
Gabapentin tablets - 600 mg, 800 mg
Zolmitriptan tablets - 2.5 mg, 5 mg
Cetirizine tablets - 10 mg
Finasteride tablets - 1 mg

Several other Oral US FDA approved ANDA products for Out - licensing without supplies. Seller will own the ANDA. Licensee will have to qualify an alternate mfg. site on their own cost.

Lamivudine tablets - 150 mg, 300 mg
Anastrazole tablets - 1 mg
Cetririzine HCl tablets OTC - 5 mg, 10 mg
Colesevelam tablets - 625 mg
Deferasirox tablets - 90 mg, 180 mg, 360 mg
Finasteride tablets - 1 mg
Glimepiride tablets - 1 mg, 2 mg, 4 mg
Levetiracetam tablets - 250 mg, 500 mg, 750 mg
Levalbuterol respules - 0.31 mg, 0.63 mg, 1.25 mg / 3 ml
Meprobamate tablets - 200 mg, 400 mg
Montelukast Sodium Chewable tablets - 4 mg, 5 mg
Nevirapine ER tablets - 400 mg
Pravastatin tablets - 10 mg, 20 mg, 40 mg
Quinapril HCl and Hctz tablets - 10/12.5 mg, 20/12.5 mg, 20/ 25 mg

Oral Products Lab Development completed along with BE studies: ANDA Products

Acetazolamide: Tablets - 125 mg and 250 mg
Clobazam: Oral Suspension - 2.5 mg/mL
Guaifensin: Extended Release Tablets - 600 mg, 1200 mg
Guifensin + Pseudoephedrine HCl Tablets - 600/60 mg, 1200/120 mg
Guifensin + Dextromethorphan HCl Tablets - 600/30 mg, 1200 /60 mg
Glycopyrrolate : Oral Solution - 1mg/5mL
Metformin: Delayed Release Tablets - 500 mg/750 mg/ 100mg
Nimodine: Oral Solution - 60 mg/mL
Nitrofurantoin: Oral suspension - 25 mg/mL
Posaconazole: Delayed Release Suspension - 400 mg/mL
Ritonavir: oral Solution - 80 mg/mL
Sodium Oxybate: Oral Solution - 500 mg/mL
Spironolactone: Oral Solution - 25 mg/mL