Mehta API Pvt Ltd:
1. About us- small molecule API CDMO, 100% family owned business, incorporated in 2007, based out of Mumbai, India, facility spread over 26,500m2. Approach with focus, agility, speed, transparency in all our projects- highly appreciated by our partners.
2. Approvals- EDQM (Swiss Medic), PMDA-Japan, China-NMPA, WHO-GMP (US-FDA inspection expected in 2026).
3. Business model- CDMO + Generics (15+ APIs commercial).
4. CDMO experience- 8+ CDMO projects delivered, includes NCE from clinical batches through to commercialization pan EU, a 15+ stage complex HPAPI amongst others.
5. Technology transfer- R&D on site enabling seamless tech-transfer. Absorbed 5+ g scale process from our partners for further optimization, scale-up and commercial + successfully transferred 2 technologies to external parties- breadth of insight into successful technology transfers across global sites, teams and cultures.
6. Solutions- phase appropriate development and manufacturing services right- route scouting, process design, establishing CQA's and CPP's, analytical method development and validations, safety studies (HAZOP, FMEA, RC1, MIE).
7. Technologies- biocataylsis (successfully executed under GMP), continuous flow (hydrogenation- at R&D), solid state chemistry (salts/ co-crystals/ polymorphs).
8. Infrastructure- 2 process development labs, analytics , 3 multipurpose cGMP blocks, 1 HPAPI (OEL 5ng/m3/8hrs) GMP block and 1 non-GMP pilot plant with SS, GL and halar coated reactors (10L- 4KL), various filtrations and drying, high vacuum distillation, high pressure hydrogenation, column chromatography, micronization and milling including HPAPI.
9. Team- 250, R&D team of 40 and expected to touch 50 by end of Q3'2025 with a dedicated project manager.
10. Investments-
1. Mixing simulation for accurate scale-up (piloting).
2. AI co-pilot for process optimization for certain key chemistries including cross coupling reactions (piloting).
3. R&D and pilot plant automation for process- digital inputs and data collection.
4. Multipurpose cGMP block (up to 10KL reactor) and hydrogenation block (up to 2KL).
Thank you.