Services
CMO / CDMO SERVICES
Tooba Pharmaceuticals Private Limited (TPPL) is a trusted Contract Development and
Manufacturing Organization (CDMO) offering end-to-end solutions for Active
Pharmaceutical Ingredients (APIs) and Intermediates.
Established in 2007, we provide comprehensive services to global innovator
pharmaceutical companies, supporting them from laboratory scale to pilot and
commercial manufacturing scales through our state-of-the-art, WHO-GMP certified
facility. Our offerings include end-to-end support — from process development and
technology transfer to validations and regulatory filings.
Our comprehensive service portfolio covers the entire product lifecycle,
including:
- Process development and optimization
- Technology transfer
- Process validation
- Regulatory documentation and filing support
CRO / R&D CRAMS SERVICES
Tooba Pharmaceuticals Private Limited (TPPL) as a CRO/R&D CRAMS service provider,
offers end-to-end research and development solutions to the global pharmaceutical
industry. We specialize in process optimization, analytical and method development,
impurity profiling & control, and troubleshooting, enabling faster and more
efficient drug discovery and manufacturing.
TPPL’s CRO services focus on developing safe, economical, and patentable API
processes based on green chemistry principles. Our expertise extends to telescoped
synthesis and regulatory dossier support (ASMF/CEP), backed by proven innovation in
molecules such as Trazodone, Mexiletine, Glycopyrrolate, Tamsulosin, Nitrofurantoin,
etc.
With a strong emphasis on innovation, quality, and regulatory compliance, TPPL has
earned the trust of pharmaceutical companies worldwide.
We deliver cost-effective,
sustainable, and high-quality solutions, ensuring every project meets global
standards and client expectations — helping our partners bring their molecules to
market faster and more efficiently.
Our Service Offerings Include (but are not limited to):
- Synthetic route identification, development and optimization
- Synthesis of niche building blocks, scaffolds, and intermediate compounds for analog generation
- Development of commercially viable and competitive alternate manufacturing routes
- Reduction of costs and process complexity to develop cost-effective and sustainable processes
- Optimization of reaction conditions to enhance yield and purity
- Integration of Green Chemistry principles to minimize by-products, waste, and environmental impact
- Focus on developing import-substitute routes to strengthen supply chain independence
- Pre-clinical and clinical compounds on multi-gram to multi-kilogram scale
- In-house preparation of Impurities and Working Standards
- Analytical Method Development and Validation
- Impurity Profiling
- Genotoxic Evaluation and Validation
- Polymorph Studies
- NDMA Risk Assessment
- Elemental Impurity Assessment
- Kilo and Pilot Scale Manufacturing
- Technology Transfer
- Stability Studies
- Documentation Support for Regulatory Filings and Approvals
Key Capabilities & Infrastructure
- Technocrats with a cumulative research experience of almost 90 years
- Processes developed for over 100+ products by our expert team
- 200+ patents credited to our scientists and researchers
- TPPL has developed patentable technologies; recently filed patent for Glycopyrronium Bromide (Application No. 202021022784)
- Dedicated Process Safety in Laboratories
- Wide range of reactors including Stainless Steel, Glass-Lined, and Glass Assemblies
- R&D Lab: 1–20 L glass assemblies for rapid process development
- Pilot Plant: 100–200 L glass assemblies for efficient scale-up
- Manufacturing capacity ranging from 1 kg to multi-tonne scales
- Hydrogenation facility available
- Photochemical Reactor available
- Capability for high-temperature reactions (up to 200°C) and high-vacuum distillations
- Exclusive Finished Block equipped with AHUs and HEPA filters for API manufacturing
- Backward integration of key raw materials to ensure supply chain reliability
- Integrated project management and planning for end-to-end process execution
- Multiple fume hoods in synthetic laboratories with efficient exhaust systems
- 2-litre high-pressure hydrogenator for specialized reactions
- Capability to perform organometallic reactions using metal catalysts
- Facilities to maintain reaction temperatures from below 0°C to +200°C
- High-vacuum distillation systems (up to 0.1 mm Hg)
- Rotary evaporators (Rota Vap) for solvent recovery and concentration
- Access to the latest scientific literature and databases for informed research and innovation
About Us
A Brief Summary of Working Procedure
• R&D Focus:
TPPL’s Research and Development (R&D) is primarily focused on the manufacturing of
Active Pharmaceutical Ingredients (APIs) and Intermediates.
• Expertise and Experience:
TPPL’s R&D team comprises technocrats with a cumulative research experience of
nearly 90 years and over 200 patents to their credit.
The team is well equipped to develop non-infringing, innovative synthetic routes for
a wide range of molecules.
• Quality Assurance:
Company management directly monitors the quality, Quality is of supreme importance
in Tooba Pharmaceuticals and supported by people at all levels, in all functions.
Our Quality Assurance (QA) and Quality Control (QC) teams conduct rigorous testing,
validation, documenting and monitoring to ensure that every product meets the
highest standards of purity, efficacy, and safety. Our facility is WHO-GMP and ISO
9001 certified and fully compliant with current Good Manufacturing Practices (cGMP).
Most importantly the management is well versed with the chemical technology &
regulatory requirements know how.
Green Chemistry
- Adoption of Green Chemistry principles to promote environmentally sustainable processes.
- Reduction in the use of hazardous reagents and optimization of solvent recovery and energy efficiency.
- Active efforts to reduce water consumption, minimize effluent generation, and implement Zero Liquid Discharge (ZLD) practices from the very first day of process development.
- Commitment to developing cost-effective, eco-friendly, and globally compliant synthetic processes.
Data Integrity
- TPPL upholds the highest standards of data integrity and confidentiality across all operations; all data is maintained to be accurate, complete, consistent, and traceable throughout its lifecycle.
- Documentation strictly follows ALCOA+ principles and records are manually maintained under controlled conditions, verified through reviews, audits, and cross-checks.
- Strict protection of client confidentiality in contract research and manufacturing; all project data and intellectual property handled with maximum discretion.
- Continuous personnel training, adherence to SOPs, and a culture of integrity ensure global quality and ethical standards.
Safety
- Safety integrated into every stage of R&D—from laboratory synthesis to pilot-scale operations.
- All personnel use Personal Protective Equipment (PPE) and follow Safety SOPs.
- Robust safety protocols for chemical handling, instrument operation, and waste management.
- Processes designed to protect operators, the environment, and product integrity.
Patent and Legal Compliance
- R&D team skilled in developing non-infringing synthetic routes for APIs and intermediates.
- Strong focus on techno-commercial feasibility while ensuring compliance with international patent regulations.
- Strategic innovation and detailed patent assessment to ensure smooth operation in regulated markets.
Cost-Effectiveness
- Continuous R&D on existing and new products to ensure techno-commercial viability.
- Development of efficient, scalable synthetic routes aligned with project timelines.
- Process optimization, yield enhancement, and resource efficiency to maintain competitive costs.
Genotoxicity
- Early identification of genotoxic impurities using literature data, risk assessments, and predictive toxicology tools.
- Development and validation of analytical methods to detect genotoxic impurities at trace levels.
- Compliance with ICH M7 guidelines to ensure the highest safety standards for human use.
NDMA (Nitrosamine Control)
- Design of R&D processes to prevent the formation of nitrosamine impurities.
- Use of safe starting materials, improved process design, and detailed risk assessments for every product.
- Routine analytical testing for nitrosamine levels to meet global safety and regulatory standards.
Make in India Initiative
- Development of manufacturing routes from basic chemical scaffolds to reduce import dependency and ensure superior quality control.
- In-house synthesis of impurities for complete control over the development process.
- Commitment to the Government of India’s “MAKE IN INDIA” initiative by using indigenous raw materials and technologies.
- TPPL endorses the Government of India's vision and mission of developing the products with indigenous sources-'Be vocal about local'.
