Abon Pharmaceuticals
Abon Pharmaceuticals, LLC is a science-based specialty pharmaceutical company focused on complex generics and proprietary products across injectable, oral, and other dosage forms with a high barrier to entry. The company emphasizes using scientific methods and modern technology to improve dosage form efficiency, enable robust processing, and enhance patient compliance. Abon is dedicated to drug delivery research, product development, and manufacturing, with a strong focus on innovation, quality, and regulatory compliance. The company has a proven track record in dosage forms, multiple patents, and a history of FDA approvals for various generic drug products.
Industries
Nr. of Employees
small (1-50)
Abon Pharmaceuticals
100 Red School House Road, Building B, Chestnut Ridge, NY 10977
Patents
Products
Generic sucralfate oral suspension (1 g/10 mL)
ANDA-approved generic oral suspension of sucralfate for gastrointestinal indications; approval received March 18, 2024.
Generic atovaquone oral suspension (750 mg/5 mL)
ANDA-approved and commercially launched generic oral suspension of atovaquone; approval received October 25, 2021; launch announced November 14, 2023.
Generic clofarabine injection (1 mg/mL)
ANDA-approved generic injectable anticancer product (single-use vial) equivalent to the reference listed drug; approval noted May 9, 2017.
Pipeline: Extended-release and transmucosal platforms (patented)
Portfolio of proprietary delivery platforms including extended-release oral dosage forms for poorly soluble amine drugs, oral transmucosal forms for hormone therapies and hypogonadism, and various long-acting injectable delivery systems (several patents issued and filed).
Generic sucralfate oral suspension (1 g/10 mL)
ANDA-approved generic oral suspension of sucralfate for gastrointestinal indications; approval received March 18, 2024.
Generic atovaquone oral suspension (750 mg/5 mL)
ANDA-approved and commercially launched generic oral suspension of atovaquone; approval received October 25, 2021; launch announced November 14, 2023.
Generic clofarabine injection (1 mg/mL)
ANDA-approved generic injectable anticancer product (single-use vial) equivalent to the reference listed drug; approval noted May 9, 2017.
Pipeline: Extended-release and transmucosal platforms (patented)
Portfolio of proprietary delivery platforms including extended-release oral dosage forms for poorly soluble amine drugs, oral transmucosal forms for hormone therapies and hypogonadism, and various long-acting injectable delivery systems (several patents issued and filed).
Services
Comprehensive physicochemical characterization of APIs, excipients and early-stage formulations to de-risk development and inform formulation strategy.
Development of formulations across oral, transmucosal and parenteral dosage forms with bench-to-pilot capabilities and support for tech transfer.
Development, optimization and validation of HPLC/GC/dissolution and other analytical methods, plus impurity and polymer characterization.
Statistical design, mathematical modeling and PK-based formulation optimization to increase predictability of in-vivo outcomes and bio/clinical study success.
Scale-up and transfer of processes from bench to pilot plant and support for partner manufacturing.
Preparation and support for regulatory filings for generic products, including ANDAs and 505(b)(2)-type dossiers and support through patent/challenge processes.
Comprehensive physicochemical characterization of APIs, excipients and early-stage formulations to de-risk development and inform formulation strategy.
Development of formulations across oral, transmucosal and parenteral dosage forms with bench-to-pilot capabilities and support for tech transfer.
Development, optimization and validation of HPLC/GC/dissolution and other analytical methods, plus impurity and polymer characterization.
Statistical design, mathematical modeling and PK-based formulation optimization to increase predictability of in-vivo outcomes and bio/clinical study success.
Scale-up and transfer of processes from bench to pilot plant and support for partner manufacturing.
Preparation and support for regulatory filings for generic products, including ANDAs and 505(b)(2)-type dossiers and support through patent/challenge processes.
Expertise Areas
- Pre-formulation and solid-state characterization
- Formulation development for oral and parenteral dosage forms
- Long-acting injectable development
- Analytical method development and validation
Key Technologies
- Scanning electron microscopy (SEM)
- Powder X-ray diffraction (PXRD)
- Differential scanning calorimetry (DSC)
- Thermogravimetric analysis (TGA)
News & Updates
On March 18, 2024, Abon received FDA approval of its ANDA for a generic version of Carafate® (sucralfate) Oral Suspension, 1 g/10 ml. The company is preparing to launch it shortly.
On November 14, 2023, Abon launched a generic version of Mepron® (atovaquone) Oral Suspension, 750 mg/5 ml. The company plans to launch more oral suspension products.
On May 1, 2023, Abon opened a new facility in Chestnut Ridge, NY, including a pilot plant, analytical laboratory, GMP manufacturing suite, and corporate office.
On October 25, 2021, FDA approved Abon's ANDA for a generic version of Mepron® (atovaquone) Oral Suspension, 750 mg/5 ml.
On May 9, 2017, Abon received FDA approval of its ANDA for a generic version of Clolar® Injection, 20 mg/20 mL, and is preparing to launch it.
On July 25, 2014, Abon settled patent litigation related to U.S. Patent No. 5,661,136, allowing Abon to launch the product on or after February 15, 2017.
On March 18, 2024, Abon received FDA approval of its ANDA for a generic version of Carafate® (sucralfate) Oral Suspension, 1 g/10 ml. The company is preparing to launch it shortly.
On November 14, 2023, Abon launched a generic version of Mepron® (atovaquone) Oral Suspension, 750 mg/5 ml. The company plans to launch more oral suspension products.
On May 1, 2023, Abon opened a new facility in Chestnut Ridge, NY, including a pilot plant, analytical laboratory, GMP manufacturing suite, and corporate office.
On October 25, 2021, FDA approved Abon's ANDA for a generic version of Mepron® (atovaquone) Oral Suspension, 750 mg/5 ml.
On May 9, 2017, Abon received FDA approval of its ANDA for a generic version of Clolar® Injection, 20 mg/20 mL, and is preparing to launch it.
On July 25, 2014, Abon settled patent litigation related to U.S. Patent No. 5,661,136, allowing Abon to launch the product on or after February 15, 2017.