Formulation Development & Manufacturing at Aryastha Life Sciences
At Aryastha, we combine scientific depth, regulatory experience, and state-of-the-art infrastructure to deliver world-class formulation development and manufacturing solutions.
Formulation R&D Capabilities
- NDA/ANDA/LCM
- Potent/Oncology
- Orals (solids & liquids)
- Injectables
- Topicals
- Nasal Sprays
- Commercial supplies
- Global regulatory compliance
- USFDA, EU, ANVISA
- Microbial Studies
- Bacterial endotoxin content
- Sterilization
Solid Oral Dosage Forms
- Tablets (IR, ER, DR, SR, GR, PR, MUPS)
- Capsules (hard/soft gelatin)
- Granules, pellets, chewing gums
- Technologies
- Hot Melt Extrusion (HME)
- Extrusion-spheronization
- Roller compaction
- Fluid-bed coating
Injectables & Parenterals
- Liquid solutions & suspensions
- Lyophilized powders (vials, PFS, depot injectables)
- Liposomes, microspheres, polymeric gels
- Ophthalmic solutions & suspensions
- Complex drug-device combinations
- Semi-Solids & Topicals
- Creams, gels, lotions, pastes
- Oral Liquids
- Solutions and suspensions (pediatric & adult formulations)
Pre-Formulation & Material Science Expertise
- Solubility Studies
- pKa determination
- Excipient Compatibility
- Polymorphic screening
- Particle Size
- Micromeritic properties
- Stability
- Potency
Analytical & Quality Support
- Method development, validation, and transfer (ICH Q2 compliance)
- Comprehensive characterization of solid & liquid formulations
- Nitrosamine testing, extractables & leachables
- Forced degradation, stability-indicating methods
- Advanced instrumentation: HPLC, LC-MS, GC-MS, UV-Vis, FT-IR, MALS detectors, Franz diffusion cell
- Microbial Studies
- Bacterial endotoxin content
Material Science
Surface morphology & solid-state characterization
Particle engineering
Solid State Characterization
- PXRD
- DSC/TGA
- DVS
- PLM
- Particle Engineering
- Rheometer- Anton Parr
- Zeta Sizer
- ICPMS
- AS
- Malvern Master Sizer
Material Science
Surface morphology & solid-state characterization
Particle engineering
Solid State Characterization
- PXRD
- DSC/TGA
- DVS
- PLM
- Particle Engineering
- Rheometer- Anton Parr
- Zeta Sizer
- ICPMS
- AS
- Malvern Master Sizer
-
- PXRD
-
- DSCTGA
-
- Zeta Sizer
-
- PLM
-
- A A S
-
- IC P M S
-
- DVS
-
- Rheometer- AntonParr
IND/NDA Program solutions
Formulation Manufacturing Infrastructure
Block A – Oncology Products
- Capacity: ~500 million units per year
- Capabilities: Tablets, capsules, clinical trial supplies
- Specialized packaging: bottle and bulk lines, blisters
- Serialization (track & trace compliance)
Regulatory Strength & Track Record
- Experience with 26+ regulatory agencies worldwide
- 100+ product approvals and 300+ products developed
- 112+ regulatory audits successfully completed
- First NDA approval from USFDA for a product developed in-house
- Expertise in NDA, ANDA, LCM, and global submissions
Block B – General Products
- Capacity: ~2 billion units per year
- Wide range of oral solid dosage forms under GMP
- Controlled environments (<20% RH) for moisture-sensitive Drug Substance/APIs
- Full ICH Zone I–IVB stability chambers
