Shilpa Medicare | Affordable Pharma Innovation in India

Advanced Formulation Development Hub

Shilpa Medicare expands its Research and Development capacity with a state-of-the-art centralized facility at Dobaspet near Bangalore for Formulation Development. The Research and Development Centre is involved in development of dosage forms including Injectables, Oral solids under Oncology and Non-Oncology categories, Transdermal and topical applications, Ophthalmic and Orally Disintegrating Films formulations.

Bangalore R&D Centre

CDMO Partnership Excellence

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.

Cutting-Edge Technology Platform

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 specialty products. Our state-of-the-art capabilities are fully equipped with analytical instruments to support evaluation of all dosage forms.

Comprehensive Analytical Capabilities

Shilpa Medicare in-house extractable & leachable facility is well positioned to support various dosage forms as well as characterization of API, impurities, excipients and packaging components. The facility provides one-stop solution for product development, analytical method development, validation, stability studies, and impurity characterization.

Formulation Development Services

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Pre-formulation Studies

Drug substance characterization, compatibility studies, analytical method development, and dosage form enabling studies

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Oral Dosage Forms

Tablets, capsules, liquids, bilayer/trilayer tablets, granulation technologies, and ODF

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Injectable Formulations

IV/IM/SC delivery, aqueous/non-aqueous, emulsions, suspensions, nanoparticles, liposomes, lyophilized

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Specialized Forms

Ophthalmic solutions/suspensions, topical applications, transdermal patches, and preservative-free formulations

Quality by Design (QbD) Approach

Our Process Development Lab meets cGMP requirements and is designed to support formulation development, process optimization adhering to principles of QbD and scale-up batches. The facility is fully equipped to support clinical supplies with varied and customizable batch sizes.

Analytical Excellence

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Method Development & Validation

ICH and USP compliant methods, 21 CFR Part 11 compliant systems

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Advanced Analysis

SEM, XRD, IVRT/IVPT, Nitroso amines testing and validation

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Extractables & Leachables

USP <666.1> compliant, LC-MS/MS, GC-MS, ICP-MS testing for all components

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Elemental Analysis

ICH Q3D elements testing for 24 metals using advanced instrumentation

One-Stop Development Solution

The Bangalore Research and Development Centre provides a comprehensive one-stop solution to customers for product development, analytical method development, analytical method validation, stability studies, characterization of impurities, and evaluating extractables & leachables for packaging components.