Profile

COMPANY INTRODUCTION

Bostal (formerly AustarPharma) is a global pharmaceutical company specializing in advanced drug delivery technologies, with a particular focus on long-acting injectable (LAI) formulations. With over two decades of development expertise and integrated global operations, Bostal is uniquely positioned to take LAI products from early formulation in the lab to full-scale commercial production.


Our leadership team brings an average of over 25 years of pharmaceutical experience, spanning formulation science, regulatory strategy, manufacturing, and commercialization. Over the past 12 years, we have built a robust platform of proprietary LAI technologies—Zpheres® (microspheres), Geleepot® (in-situ gel), and Kriztols® (nano/microcrystal systems)—designed to deliver sustained efficacy, improved adherence, and differentiated clinical performance.


In 2009, Bostal acquired a 43,000 sq. ft. FDA- and EU-approved cGMP manufacturing and testing facility in Edison, New Jersey, formerly owned by Abbott Laboratories. This world-class site, with an annual capacity of ~1 billion oral dosage units, supports end-to-end execution of drug development, including clinical trial material production, commercial supply, and regulatory-compliant global distribution. The facility is also licensed to handle controlled substances (CII–CV) and high-potency compounds.

History

GLOBAL LAI CAPABILITIES – FROM LAB TO COMMERCIAL SCALE

  • R&D and Formulation Development: Integrated drug delivery labs in the U.S. and China for early-stage development of LAI products using proprietary platforms.


  • Analytical & Stability: Fully equipped with UPLC/HPLC systems, chromatographic data networks, and ICH-compliant stability chambers.


  • GMP Manufacturing: Proven track record of passing FDA and EU inspections; capable of scaling from pilot to commercial batches.


  • Regulatory & IP Expertise: Deep experience with 505(b)(2) and ANDA pathways, enabling strategic global submissions.


  • Global Partnerships: Proven collaboration model with pharma and biotech companies worldwide to co-develop and commercialize high-impact LAI therapies
GMP Area Production
WE STRIVE TO DISCOVER NEW WAYS OF OVERCOMING MEDICAL CONDITIONS AND CURING DISEASES FOR OUR PATIENTS.
Manufacturing
cGMP

In 2009, acquired an FDA and EU approved cGMP commercial manufacturing facility (oral dosage forms, 43,000 sf2) from Abbott at Edison NJ (~1 billion units annually).

We have a wide range of pharmaceutical processing technology and capability to meet various development and manufacturing needs.

Facility and Equipment

State-of-the-art facilities and advanced equipment ensuring precision, efficiency, and compliance in pharmaceutical innovation.  In 2009, acquired an FDA and EU approved cGMP commercial manufacturing facility (oral dosage forms, 43,000 sf2) from Abbott at Edison NJ (~1 billion units annually).

01

GMP AREA

The facility passed eight FDA GMP inspections in June 2011, June 2012, December 2013, May 2016, June 2017, Jan. 2018, May 2018 and Jan. 2019.

02

UPLC & HPLC

UPLCs: Waters with Empower 3 workstation.

HPLCs: >25, Shimadzu, Perkin Elmer and Agilent. Client/Server Chromatographic Data Management System with UV, PDA, RI, Florescence Detections.

03

Stability Chambers

Stability Chambers to offer precise temperature and humidity control, enabling thorough testing and evaluation of drug shelf life to ensure long-term effectiveness and safety.