Quality and Manufacturing
Quality is integrated into every stage of our manufacturing process, from raw material qualification to finished Active Pharmaceutical Ingredients (APIs).
Quality Control
Rigorous quality control procedures and comprehensive testing protocols ensure that every batch of API is manufactured under GMP conditions and consistently meets defined specifications and regulatory requirements. The laboratory is equipped with modern instrumentation including HPLC, GC, UV-Visible Spectrophotometers and conducts stability studies under ICH guidelines to support product shelf life and registration. A well-equipped in-house microbiology laboratory ensures compliance with microbiological limits for water systems, processing areas and finished products.
Quality Assurance
Our Quality Assurance team ensures adherence to Standard Operating Procedures (SOPs) while maintaining a robust Quality Management System (QMS) across all operations at our Vapi, Gujarat facility. The QMS governs documentation control, change control, deviation and CAPA management, and batch review and release, ensuring traceability and consistency from raw material to finished API.
Regulatory Affairs
Our Regulatory Affairs team prepares prepares technical documentation and CTD dossiers, supporting efficient product registration across global markets. We maintain Drug Master Files (DMFs) for our molecules and can support customer filings in regulated and semi-regulated markets.
Our facility is built and operated to produce specialty Active Pharmaceutical Ingredients efficiently and in complete regulatory compliance.
Manufacturing Capabilities
We manufacture 50+ APIs across multiple therapeutic and specialty categories, including narcotic analgesics, steroids, bronchodilators (DPI/MDI), vitamin B12 derivatives, antimalarials, dermatology and injectable-grade APIs. We manufacture these APIs using a wide range of complex synthetic processes supported by our integrated manufacturing infrastructure. All operations comply with current Good Manufacturing Practices (cGMP) and established regulatory standards.
Pilot Plant and R&D
The manufacturing unit is supported by pilot-scale units and an in-house R&D department, enabling process development, scale-up and continuous improvement. This allows us to take our products from the laboratory to the market from a single site.
Location and Logistics
Our facility is in Vapi, Gujarat, India — approximately 160 km from Mumbai, with access to JNPT / Nhava Sheva port and Mumbai International Airport, supporting reliable export logistics to over 40 countries.
Our Clients
