Research & Development
Propelled by our overall mission—“Provide Quality Medicines Throughout the World at Affordable Prices,” Micro Labs’ R&D activities are aimed at delivering highly- effective medicines & treatment that improve the quality of millions of people’s lives across the globe. Our world-class R&D facilities at our Bangalore and Mumbai locations host over 400 scientists who are experts in strategic sourcing to global regulatory submissions including formulation development, analytical development, validation, packaging development, technology transfer, bio-equivalence, IP management, to name a few.
Driven by our maxim that, “Health is in Small Details,” we are pioneers in developing complex formulations for conventional as well as novel drug delivery systems including solid orals, topicals, liquids, and sterile products solely based on scientific research data and expert insights.
Our strong R&D skills coupled with our unique understanding of the local regulatory body have enabled successful registrations of Micro Labs’ products in markets worldwide.
The highlights of the R&D centres at Micro Labs include:
- Development of Generics
- Strict compliance IPR / Non-infringing route
- Infrastructure includes a facility for scale-up & validation
- Capability includes handling complex chemistries
- Regulatory compliant development & scale-up
- File EU-DMF / E-COS / US-DMF
- 8 new molecules under development
The dosage forms and technologies developed by our R & D include:
- Immediate Release Solid Dosage Form (IR)
- Sustained Release Tablet Technology (DR)
- Effervescent Technology
- Enteric Coated Technology
- Direct Compression Technology
- Oro dispersible tablet form
- Chewable tablet form
- Hot-melt extrusion technology
- Tablet in capsule technology
Once a new pharmaceutical product is developed, it undergoes the following screening to comply with health standards:
- Conceiving and identifying product profile
- Pre-formulation studies
- Lab formula development for stability & validation
- Scale-up for process optimization/validation
- Analytical method development
- Pilot-scale manufacturing in GMP facility (Clinical supplies)
- Stability studies as per ICH guidelines
- Dossier preparation for submission/technical assistance for contract manufacturing
- Data management (for transfer to customer/ regulatory affairs)