From complex molecules to market-ready drug products — our state-of-the-art R&D and manufacturing capabilities deliver quality, compliance, and scalability for global regulated markets.
Our state-of-the-art R&D lab at Hosur, Tamil Nadu provides end-to-end formulation solutions under a Quality by Design (QbD) framework for regulated markets worldwide.
From high-volume generics to advanced multi-layer drug delivery systems, Oral Solid Dosage (OSD) platform supports all major dosage forms through validated manufacturing processes designed for global regulated markets.
| Dosage Form | Available Types / Variants |
|---|---|
| Tablets | Immediate Release (IR), Sustained Release (SR), Delayed Release (DR), Extended Release (ER), Bilayer Fixed-Dose Combinations (FDCs) for incompatible APIs, Effervescent Tablets, Film-Coated Tablets, Sugar-Coated Tablets, and Enteric-Coated Tablets. |
| Capsules | Hard Gelatin Capsules (Powder-in-Capsule, Pellet-in-Capsule) and Specialized Filling Technologies (Tablet-in-Capsule). |
| Sachets & Powders | Advanced taste-masking solutions for fast-melt and pediatric formulations utilizing polymer-coating and ion-exchange technologies. |
Critical for fast-melt and pediatric formulations using polymer coating and ion exchange technologies.
Precision engineering for low-dose actives ensuring content uniformity across large batch sizes.
Expert selection of functional coatings for gastro-retentive and modified-release profiles.
Enhancing drug targeting and reducing toxicity through lipid-based encapsulation.
Orally Disintegrating Tablets (ODTs) for rapid dissolution and improved patient compliance.
Increasing bioavailability for drugs with narrow absorption windows in the upper GI tract.
BCS Class II & IV strategies using solid dispersions, micronization, and surfactant systems.
High-precision development of aqueous and non-aqueous sterile preparations for technology transfer and commercialization.
Sterile, Isotonic, and pH-optimized formulations for maximum ocular comfort and bioavailability.
Every formulation is developed with the final regulatory submission in mind — our processes are built to satisfy CTD/eCTD requirements for the US, EU, and other highly regulated territories.
Comprehensive data packages satisfying submission requirements for US FDA, EMA,MHRA, TGA. End-to-end regulatory support for global submissions, including PIND, IND, NDA, Scientific Advice, PIP, and expedited pathways such as Fast Track Designation (FTD), Special Protocol Assessment (SPA), and Drug Development Tool (DDT) programs, backed by comprehensive data package preparation and regulatory strategy expertise.
Design of Experiments (DoE) to define design space and ensure process ruggedness from lab to commercial scale.
Seamlessly moving products from pilot-scale development to commercial manufacturing with full documentation.
Our state-of-the-art OSD facility in Whitefield, Bangalore is certified by UK MHRA, EU GMP (DKMA), and TGA, meeting stringent global standards.
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| Category | Infrastructure |
|---|---|
| Manufacturing | High capacity Granulation suites with closed loop powder transfer system to reduce product exposure with online milling. Small capacity granulation suite for Pilot scale batches. Granulation suites capable for handling product under low humidity controls. Manufacturing suites equipped with clean-in-place (CIP) system. |
| Compression | High speed Compression machines with online metal detection and De-dusters |
| Coating | High capacity Auto coaters |
| Tablet or Capsule Inspection | 100% Inspection before packing |
| Encapsulation | Automatic Capsule Filling Machine (Powder, Pellet & Tablet in Capsule) |
In-house packaging development capabilities, supported by a dedicated design team for creating printed packaging designs and artwork.
Full Track & Trace compliance across every level of packaging — from unit pack to shipper carton — meeting FMD/EU, and global serialization mandates for regulated market supply chains.
State-of-the-art laboratory ensures 100% data integrity through 21 CFR Part 11-compliant systems and full adherence to ICH guidelines. Equipped with advanced analytical instrumentation and comprehensive in-house microbiology capabilities, we provide reliable testing support for product development, quality control, and regulatory submissions. Our robust quality systems ensure accurate, compliant, and high-quality results.