Research & Development Centre, Bangalore
Shilpa Medicare expands its Research and Development capacity, has state of Art Centralized facility at Dobaspet near Bangalore for Formulation Development. The Research and Development Centre is involved in development of dosages forms e.g. Injectables, Oral solids under Oncology and Non – Oncology categories, Transdermal and topical applications, Ophthalmic and Orally Disintegrating Films formulations.
To ensure drug products, including drug delivery products, are designed to be as safe, efficacious and reproducible as possible for clinical and commercial use, it is important to collaborate with a contract development and manufacturing organization (CDMO) with the right formulation development and technology expertise early in the drug development process. Shilpa Medicare R&D Centre is well equipped for development of NCEs, Generics, Complex Generics formulations and new dosage forms involving Nano and micro technologies like liposomes, Nano particles and speciality products.
Our state of art capabilities is fully equipped with analytical instruments, supports to evaluate all dosage forms. Shilpa Medicare in-house extractable & leachable facility is well poised to support in various dosages forms as well in characterization of API, impurities, excipients and packing components.
The new Research and Development Centre is one stop solution to customers for Product development, analytical method development, analytical method validation, stability studies, characterization of impurities and evaluating extractable & leachable for packing components. Process Development Lab is meeting cGMP requirements, is designed to support in formulation development, process optimization adhering to principals of QbD and scale – up batches. The facility is fully equipped to support in clinical supplies.
What we Offer as Services-
Drug Development Activity
- Pre-formulation Studies
- Drug substance / API characterization
- Drug excipient compatibility studies
- Analytical method development
- De formulation studies
- Dosage form enabling studies.
- Dosage Form Development
- Oral Dosage forms; Tablets, Capsules, liquids, Hard Gelatin Capsules, High Shear Granulation, Bilayer tablets, Trilayer tablets, dry & wet granulation, ODF
- Ophthalmic; Multiple formulation; Solutions, Suspensions, Micro Emulsion, Gels, Preservative free formulation
- Topical forms; Creams, gels, lotions, ointments, sprays, Transdermal patches: films
- Injectables; Intravenous, Intramuscular, Subcutaneous
- Aqueous and non-aqueous
- Suspensions (aqueous and non-aqueous)
- Nano particles
- Prefilled syringes
- Complex injectable formulations
- Analytical method validation
- Stability studies
- Method Development and Validation; as per ICH and/or USP <232 >/ <233>
- SEM Analysis
- IVRT, IVPT
- Nitroso Amines; 4 or 6 Nitoso amines, validation, and testing
- Extractables and Leachables; USP < 666.1>, non- Volatile, semi-Volatile, Volatile, screening of metals; LC-MS/MS, LC-MS, GC-MS,HC-GC-MS,ICP-MS, ICP-OES
- Elemental analysis: ICH Q3D elements (24 metals)
- 21 CFR Part 11 compliant
- GMP Facility
- BA/BE and Clinical Batches execution
- Dedicated area for Orals (potent and General) and complex formulation in injectable and ophthalmic formulation
- Varied and customisable batch size