Aarti Pharmalabs Limited (APL) is one of the leading small molecules CDMO in India which offers Contract Development and Manufacturing Services (CDMS) for drug substance (NCE, RSM, Intermediates) projects. We offer these services to global innovator pharmaceuticals and biotech companies for their small molecules NCE drug development programmes from lab scale to pilot and manufacturing scales focusing on the clinical phases (Ph-I/II/III), launch and commercial phase projects.
Our value proposition is that we provide these CDMO services to meet our clients needs with dedicated scientific and project teams, rapid development, manufacturing and act as an extension to our client’s laboratories. We want to be the “preferred CDMO partner” for our clients and want to help our clients to bring their molecules to market faster and make them successful. Our company’s culture is that we truly recognise the trust our clients place in us with their development projects.
For CDMO Services Enquiries mail us on:
cdmo@aartipharmalabs.com
Service Offerings
- Synthetic Route Scouting and Design
- High-end Process Development and optimization using DOE and QbD techniques
- Analytical method development and validations
- Impurity Profiling
- Genotoxic evaluation and validations
- Salt Screening and polymorph studies
- Custom Synthesis from kg to multi kg scales
- Kilo and Pilot Scale Manufacturing (non-GMP and GMP) for Tox batches
- Drug substances (APIs/NCEs, KSMs, RSMs, intermediates) manufacturing for Clinical supplies (Ph-I/II/III), launch and commercial phases
- HPAPIs (Anti-cancer, cytotoxic) steroids development and manufacturing
- ICH Stability Studies
- CMC documentation support for Regulatory filings and approvals
Key Capabilities
- Average years of experience for workforce: 10+ years
- Process for more than 200+ products developed in lab on Kilo Scale
- More than 100 products to commercial level
- Process safety and process engineering/integration labs
- Broad range of reactors (Stainless steel, Glass lined, Hastelloy)
- 10 - 50 lit reactors in kilo lab and 100 - 500 lit reactors in pilot plant for fast process optimization and scale up
- Manufacturing strength from 1KG scale to 500 MT scales per year
- Flow Chemistry from lab scale to manufacturing scale
- Continuous hydrogenation facilities from lab scale to manufacturing scale
- Cryogenic reactors operating within temperature range up to -100oC
- High temperature reactions up to +200oC and High vacuum distillations
- High potent products development and manufacturing (OEL: 1 - 10 µg / m3; OEB: 4)
- Exclusive Sterile block for Oncology APIs
- Backward integration of key raw materials
- Integrated Project management
Manufacturing Plant Infrastructure
- USFDA, EUGMP, EDQM, KFDA, COFEPRIS approved plant (Total Volume: 225+ KL)
- USFDA approved plant (Total volume: 550+ KL)
- USFDA approved plant (Total volume: 30+ KL)
- Total volume: 800+ KL
- Another 370+ KL capacity under expansion (Greenfield Project)
- One dedicated Anticancer/Cytotoxic block
- One dedicated Corticosteroid block
- Exclusive Sterile block for Oncology APIs
- One dedicated Hydrogenation block
- Several multipurpose blocks
R&D Infrastructure
- Around 90 fume hoods in synthetic labs with efficient exhaust systems
- 5 Kilo Labs
- 100ml to 2 Litre high pressure vessels
- Automated lab scale jacketed reactors
- Reactions up to 100kg/cm2 pressure using noble metal catalysts
- Facilities to maintain reactions from -100oC to +200oC temperatures
- High vacuum distillations (0.1mm Hg)
- Column chromatography on kilogram levels for high purity chemicals
- Sci-finder/Reaxys/Orbit.com used for literature research
Global Accreditations
- USFDA
- EU GMP
- EDQM
- KFDA
- COFEPRIS
- Local WHO GMP
- EHS Audits were done as per PSCI principles
