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Shilpa Medicare Ltd., Unit-VII – Analytical Services Lab & Bio Analytical Lab

Shilpa Medicare Limited Unit-VII is a three storied, Approx. 40,000 Sq. ft building. The ground floor houses sales, marketing, business development, etc. pertaining to Formulation’s division. The first floor has a central Analytical Services Laboratory and the second floor has a Bioanalytical laboratory. The building is spread over almost 2100 Sq. Yrds. The center is involved in handling analytical and bioanalytical activities of Oncology and Non – Oncology Injectable, Oncology and Non – Oncology ODF, Transdermal or topical applications, Ophthalmic and Orally Disintegrating Films formulations.

Analytical Services

There is a team of qualified, experienced and well-trained professionals in the Analytical Services department with the expertise to perform the method validation, method transfer in Analytical Services for various dosage forms like solid orals and parenteral drugs. Further, each of the qualified professional has hands-on experience in different dosage forms.

The Analytical Services department is equipped with state-of-art analytical equipment for testing of raw materials, packing materials and finished products. This laboratory operates under cGMP and the oversight of the Quality team. Besides testing of pharmaceuticals, the laboratory also conducts analytical method validation, method transfer and other activities like physiological compatibility, regulatory support etc.

Apart from the bioanalytical Laboratory and Analytical Services, Shilpa Medicare Limited Unit-VII is also comprising of multiple cross functional teams for e.g. but not limited to business development, clinical affairs department, intellectual property management, marketing, packaging, pharmacovigilance and quality assurance departments which are part of formulation division of company.

Regulatory Approvals

Analytical Lab is approved with USFDA (FEI # 3019773458), DCA, CDSCO, DSIR, NABL and GLP certificate from DCA

Site is approved for Occupational Health & Safety Management System (ISO 45001:2018), Environmental Management System (ISO 14001:2015), Energy Management System (ISO 50001:2011),

Bioanalytical Laboratory

Shilpa Medicare Ltd, Bioanalytical laboratory is a GLP compliant laboratory which can undertake method development, validation of bioanalytical methods, bioanalysis for therapeutic drug monitoring (TDM) studies, and pharmacokinetic (PK) services that support bioavailability (BA), bioequivalence (BE), and other exploratory studies.

Our team has qualified, GLP certified and experienced professionals with vast and relevant experience in method development, method validation and bio analysis for complex bio analytical assay such as chiral compounds, compounds having metabolite back conversion, unstable compounds, endogenous compounds, liposomal products, hormones, amino acids, vitamin and protein bound drugs. A dedicated team for quality control and sample management and archival of documents is also present.

Our independent quality assurance team closely monitors each activity to ensure compliance with standard operating procedures and protocols, as well as applicable national and international regulations.

The bioanalytical laboratory is spread over 3500 square feet and is equipped with qualified technicians and state-of-the-art equipment. Our state-of-the-art infrastructure includes high end instrumentation and the latest technology platforms that enable us to offer a comprehensive set of advanced services with reduced lead times and on-time delivery.

The laboratory uses liquid chromatography with tandem mass spectrometry (LC-MS/MS) instrumentation such as API 4500 with electrospray ionization (ESI) and atmospheric pressure chemical ionization (APCI) sources to analyze small molecules, peptides, enantiomers, and large molecules, having capacities to analyze 20,000 samples per month.

Low temperature freezers of -20ᵒC and -70ᵒC, having a storage capacity of more than 40000 samples are available and are fully controlled, monitored and equipped with temperature monitoring alarm system.

All instrument software are validated according to international regulations including 21 CFR part 11

The lab is able to achieve excellent chromatographic separation with minimal cycle time at low quantitation limits – often, at the picogram level. This approach allows us to support a variety of studies, including rapid turnaround for dose escalation decisions.

Regulatory Approvals

Our bioanalytical laboratory is equipped to meet the requirements of various regulatory bodies such as, CDSCO, US FDA, Brazil’s National Health Surveillance Agency (ANVISA), Medicines and Healthcare products Regulatory Agency (MHRA), and the European Medicines Agency (EMA), etc.