Products

Products & Collaboration


Bostal brings deep expertise in drug delivery science, pharmaceutical processing, and regulatory strategy to support the development of high-barrier, value-added formulations. Our R&D team combines scientific innovation with hands-on experience across a wide range of dosage forms and delivery technologies — supporting both new chemical entities (NCEs) and established molecules.

TechnologY

Our strong expertise in IP and technology assessment and experience with the FDA regulations and the U.S. generic pharmaceutical market also enables us to provide turn-key solutions to our international investors who want to enter into the U.S. generic market, from project evaluation to product development, bioequivalence evaluation, ANDA submission, commercial manufacturing and sales & marketing following ANDA approval.

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Platform Technologies & Capabilities


1. Water-Insoluble Drug Delivery

Advanced formulation approaches to enhance solubility and bioavailability of poorly soluble APIs.


2. Controlled-Release (CR) Platforms

Technologies that enable tailored release profiles for enhanced efficacy and patient convenience:

• Osmotic pump systems

• Matrix systems (erosion/diffusion)

• Film-based CR coatings

• Pulsatile delivery systems


3. Dosage Form Processing Technologies

Comprehensive capabilities for solid oral and specialty formulation development:

• High-shear granulation, fluid bed drying, blending

• Fluid bed spray coating (top/bottom; Wurster)

• Roller compaction, nanocrystal processing

• Tablet compression (single-/multi-layer), pan coating

• Capsule encapsulation (powder and pellets)

Drug Development & Regulatory Expertise

We offer full-spectrum drug development capabilities supported by decades of regulatory experience across major markets:

• In-depth formulation and project evaluation expertise

• Regulatory familiarity across U.S., EU, Japan, and China

• Extensive experience with 505(b)(2), ANDA, IND, and NDA pathways

• Strong CMC capabilities and FDA interaction history for successful submissions

Strategic Partnerships & U.S. Market Access

Bostal actively partners with global pharmaceutical companies and investors to co-develop, register, and commercialize advanced formulations for the U.S. market. We provide end-to-end support across the value chain — from technical assessment to regulatory approval and product launch.

Contract Development & Manufacturing Services

• Formulation & analytical development

• CMC support for IND, NDA, and ANDA applications

• Non-GMP prototype manufacturing

• Clinical supply manufacturing (Phases I–III, cGMP)

• Commercial-scale cGMP manufacturing

Product Portfolio

Commercial Generics

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Methocarbamol

Brand – Robaxin

Form – Tablet

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Alendronate Sodium

Brand – Fosamax

Form – Tablet

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Clinical-Stage Pipeline (505(b)(2))
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Semaglutide LAI

A long-acting injectable version of semaglutide developed to enhance patient adherence and market competitiveness in metabolic disease.

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Brexpiprazole LAI 1M

A once-monthly long-acting formulation for schizophrenia and other CNS disorders, designed to offer sustained symptom control and improved compliance.

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Development Pipeline