Topiox Research Centre provides integrated services in formulation development, analytical testing, bioequivalence assessment, regulatory strategy, and custom API synthesis to accelerate drug development from concept to commercialization.
About Topiox Research Centre
Topiox Research Centre is an agile pharmaceutical R&D organization focused on the development, optimization, scale-up, and technology transfer of generic and 505(b)(2) drug products.
We operate our own state-of-the-art laboratories, where our in-house scientific teams conduct independent research and development activities across formulation, analytical, and synthesis domains.
Our capabilities span multiple delivery systems including topical, transdermal, ophthalmic, otic, parenteral, pessaries, inhalation, inserts, and other specialized dosage forms, aligned with global regulatory expectations.
Our Practice Areas and Expertise
All our services are supported by fully equipped in-house laboratories, ensuring end-to-end control over the research, development, and quality evaluation process.
Formulation Development
We offer comprehensive formulation development services for oral, injectable, topical, ophthalmic, and peptide-based drug products, ensuring optimal bioavailability, stability, and patient compliance.
Analytical Testing Services
Our analytical development laboratory provides method development and validation, stability studies, raw material characterization, in-vitro release testing (IVRT), extractables and leachables (E&L), and other regulatory-compliant testing per ICH Q2(R2) standards.
Q3 and In-vitro Bioequivalence
We specialize in Q3 physicochemical characterization and in-vitro bioequivalence studies for semi-solid and topical dosage forms, in alignment with FDA and EMA regulatory requirements.
Regulatory Filing Support
We support regulatory submissions including 505(b)(2), ANDA, NDA, and IND, providing strategic guidance to ensure dossier quality, regulatory compliance, and faster market access
Synthesis Department
Our synthesis division focuses on custom development of APIs, excipients, and impurities, supporting both R&D and commercial manufacturing needs under strict cGMP and ICH Q11 guidelines.
About Founder
Dr. Lalatendu Panigrahi is the founder of Topiox and has over 25 years of experience in pharmaceutics. He is an expert in developing new drug formulas. Dr. Panigrahi has a Ph.D. in Pharmaceutics from Jadavpur University, Kolkata. He has led many important projects involving special drug delivery methods, like semisolid, microsphere, and transdermal systems. He has also passed several US FDA inspections without any issues and helped get approval for more than 50 drug applications. Dr. Panigrahi is not just a scientist but also a great leader.
Dr. Lalatendu Panigrahi
Founder of Topiox
Who we are
Topiox Research Centre Pvt. Ltd., established in March 2021, is a dedicated pharmaceutical research and development organization. We specialize in the development, optimization, scale-up, and technology transfer of both generic and 505(b)(2) drug products.
Our core expertise lies in complex dosage forms across various routes of administration, including:
- Topical & Transdermal
- Ophthalmic & Otic
- Parenteral & Pessaries
- Inhalation & Inserts
- Specialized and novel drug delivery systems (ODDS & NDDS)
These products are developed with the goal of meeting global regulatory standards and achieving successful commercialization in regulated and semi-regulated markets.
🔬 In-House Laboratories & Technical Departments
Topiox operates fully equipped, in-house laboratories, enabling complete control over research, development, and quality processes. Our technical infrastructure includes:
- Formulation and Development Laboratory – Conducts formulation R&D for diverse dosage forms, supported by in-process and final product testing.
- Analytical Development Laboratory – Offers method development, validation, stability studies, and other analytical services for internal and external clients.
- Synthesis Department – Focuses on the development of Active Pharmaceutical Ingredients (APIs), excipients, and impurity profiling.
- Analytical Service Department (PTL) – Provides contract-based analytical testing services.
- Information Technology and Quality Assurance Department – Ensures data integrity, regulatory compliance, and robust documentation aligned with ICH Q10 quality system principles.
Together, these departments are supported by a competent Administrative Division, enabling efficient operations and project execution.
Read Our Latest Blogs
The Importance of Formulation Development in Modern Pharmaceuticals
The Importance of Formulation Development in Modern Pharmaceuticals
Lifecycle Management in Pharmaceutical R&D: Ensuring Long-Term Success
Lifecycle Management in Pharmaceutical R&D: Ensuring Long-Term Success
How Analytical Method Validation Ensures Quality and Safety in Drug Development
How Analytical Method Validation Ensures Quality and Safety in Drug Development