Manufacturing Excellence

Precision, process integrity, and global compliance, the pillars of our production ecosystem.

World-Class Facilities

Rraynex operates complementary, WHO-GMP-certified campuses that anchor multiparticulate and API production for global customers. Pelletization, coating, granulation and analytical QA run in parallel with centralized HVAC, purified utilities and automated data capture so every batch is documented end-to-end.

Our Manufacturing Footprint

Two sites power the network: a multiparticulate specialist unit at Boisar in Tarapur MIDC, and an API and intermediates campus in Saykha, Gujarat. Each location is designed for scalability, regulatory compliance and transparent data flows, giving customers confidence from development through commercial supply.

Our Boisar site is the engine behind multiparticulate manufacturing. The campus is tuned for scale, giving customers the ability to grow volumes quickly without compromising GMP discipline.

Today the facility delivers 40 MT each month, with a new 70 MT block on track for completion by January 2025. Regulatory approvals stretch across WHO GMP, CIS, LATAM and wider ROW markets, and the export desk actively services Bangladesh, Pakistan, Russia, Mexico, Sri Lanka, Egypt and Iran. Because intermediates, APIs and pellets are produced on the same campus, the supply chain remains tightly governed and costs stay predictable. The leadership bench—Milind Gadkari (44+ years, ex Pelletech EU GMP), Mihir Patel (15+ years) alongside promoters Nishit Gupta and Raina D. Desai—keeps sourcing, quality and operations decisive. Every audit trail is fully documented with open and closed DMF modules, VQM support, TSE/BSE/MSDS packs and stability data on file.

Our newest facility in Gujarat extends the network into complex chemistry, pairing modern utilities with an execution team that has already validated multiple launches.

The campus houses twenty reactors spanning 1 KL to 8 KL capacities across GLR, SSR and glass-lined formats, supported by a dedicated QC laboratory and spacious utilities. Certified for WHO GMP, CIS, LATAM and broader ROW markets, the site mirrors the market reach of Boisar with a focus on Bangladesh, Pakistan, Russia, Mexico, Sri Lanka, Egypt and Iran. It is already licensed to supply Omeprazole API along with Hydroxy, Chloro and Sulphite intermediates. Rabeprazole and Domperidone programmes have cleared lab scale with commercialization targeted for March 2025, while Itraconazole, Lansoprazole and Esomeprazole move steadily through the pipeline. Customer audit packs and tech-transfer teams are on standby to shorten onboarding timelines.

Key Manufacturing Equipment

Our technology backbone consists of scalable, validated equipment enabling precision at every production stage. Below are some of the key systems integral to our operations.

Fluid Bed Coater

Our fluid bed coater enables efficient top and bottom spray coating of pellets and multiparticulates. It supports enteric, sustained, and color coating applications with precise control of weight gain and uniformity.

Used for enteric & sustained release formulations.

Coating Pan

Automated coating pan for film and sugar coating processes. It allows programmable spray parameters, pan speed, and drying cycles to ensure consistent tablet and pellet coating results.

Ideal for mid-scale batches and coating uniformity studies.

Fluid Bed Drier

Used for rapid and uniform drying of granules and pellets under controlled temperature and airflow. Equipped with PID controllers for precision and repeatability of moisture profiles.

Ensures product consistency and stability.

Rapid Mixing Granulator

High-shear wet granulation system with variable impeller and chopper speeds. Capable of handling medium-to-large production runs with robust granule density control.

Capacity: up to 2 tons per batch.

Pellet Blender

Precision blender designed for uniform mixing of pellets, granules, and powder blends. The system ensures homogeneity while maintaining material integrity.

Multiple blender types — V, double cone, and tumble.

HPLC Analytical System

High Performance Liquid Chromatography (HPLC) units for impurity profiling, assay, and stability testing. Fully validated methods with automated sample injection.

Critical QC instrument for release and validation.

Dissolution Apparatus

Automated dissolution testers compliant with USP methods (paddle, basket, and flow-through). Used to monitor drug release kinetics and ensure bioequivalence targets.

Supports R&D and batch release analysis.

Quality Control Laboratory

Fully equipped QC lab performing analytical, physical, and microbiological testing. Each process is documented with controlled data systems ensuring transparency.

Supports method validation & stability programs.

HVAC and Controlled Areas

Dedicated HVAC system ensures cleanroom-grade temperature, humidity, and air-pressure controls. Designed to meet WHO-GMP and regulatory cleanroom standards.

Ensures aseptic & GMP-compliant environment.