The new CGMP facility included two dedicated areas, one for oral dosage and the other for parenteral products for international market distribution. Solid dosage capabilities included wet and dry granulation through compression, coating, and final packaging. Parenteral operations supported formulation and primary/secondary packaging. Various isolation technologies were assigned to provide for primary containment and facility elements provided transition area supporting secondary containment and CGMP zoning (FDA, EMEA, MHRA, WHO). Produced materials will be used for submission and commercial use with batch sizes ranging from 0.75kg to 60kg.
- Cyto Block: 30,700sf
- Anti-hormonal Block: 16,000sf
- Utility Block: 9,200sf
Region: Southeast AsiaCountry: IndiaOffice: Mumbai
Services: Consulting, Architecture, Construction Management, Commissioning, Qualification & Validation, DesignIndustries: Pharmaceutical, Oral Solid DosageFacility Type: Manufacturing