MANUFACTURING FACILITY
Mahape (Navi Mumbai)
Our state-of-the-art manufacturing unit, located in Navi Mumbai, spans 1500 sq. m. and adheres to WHO cGMP guidelines. The facility is equipped with modern infrastructure, advanced equipment, and dedicated departments for formulation, quality assurance, quality control, warehousing, and production. With a production capacity of 720 MT per annum and plans for expansion to 1080 MT per annum, the unit is staffed by a skilled workforce of approximately 125 employees
Key Features
- Dedicated areas for production, packaging, and quality control
- Advanced warehouse with separate sections for raw materials and packing
- Stability chambers for real-time and accelerated testing
- Cutting-edge coating facilities with multiple autocoaters
- Comprehensive HVAC and water purification systems ensuring controlled environments
Key Departments
Quality Assurance Department:
- Quality Management System (QMS)
- Validations & Qualifications
- Training programs
Quality Control Department
- Wet Laboratory
- Instrument Laboratory
- Microbiology Laboratory
- Equipped with the advanced Colour Matching Spectrophotometer for accurate testing
Regulatory Assistance
Novo Excipients provides full regulatory assistance to support US DMF, CHINA DMF and EU compliance, offering documents such as:
- GMP and HALAL certificates
- ISO 9001:2008 certification
- Acute Oral Toxicity Study Data
- Stability Study Data
- Non-GMO, TSE/BSE, and Allergen-Free Statements
- GRAS ingredient statements
- Material Safety Data Sheet (MSDS)
- And many more…
Upon customer request, we provide our pharmaceutical specialty excipients with certificates detailing potential risks related to Nitrosamine and elemental impurities, in full compliance with regulatory standards.
Our Novoseries products are free from Nitrosamine impurities.
Our facility is regularly audited by Indian and international regulatory organizations, as well as by our customers, to maintain the highest standards. We source raw materials from certified pharmaceutical-grade vendors and ensure strict quality control throughout the production process.