Shilpa Medicare Limited
Pharmaceutical Excellence Since 1987

Unit VII - Nacharam Analytical Services Lab

State-of-the-art analytical and bioanalytical laboratory with USFDA, GLP certification and ISO compliance, supporting 20,000+ samples per month

Advanced Analytical & Bioanalytical Services Center

Shilpa Medicare's Unit VII at Nacharam is a comprehensive analytical services center housed in a three-story, 40,000 sq. ft. facility spread over 2,100 square yards, dedicated to providing world-class analytical and bioanalytical testing services.

This state-of-the-art facility supports analytical and bioanalytical activities for diverse formulations including oncology and non-oncology injectables, oral dosage forms, transdermal applications, ophthalmic products, and orally disintegrating films.

Facility Overview

40,000 Sq. Ft. Facility

Three-story building with dedicated floors for analytical services, bioanalytical lab, and business operations

Comprehensive Testing

Supports oncology/non-oncology injectables, ODF, transdermal, ophthalmic, and oral films

Multi-Functional Teams

Cross-functional teams for business development, clinical affairs, IP management, and regulatory support

Laboratory Divisions

Analytical Services Laboratory (1st Floor)

Equipped with state-of-the-art analytical equipment operating under cGMP standards and Quality team oversight.

Core Capabilities:
  • ✓Method validation and method transfer
  • ✓Raw materials, packaging, and finished product testing
  • ✓Solid oral and parenteral drug analysis
  • ✓Physiological compatibility and regulatory support
Expert Team
Qualified, experienced professionals with hands-on expertise across multiple dosage forms

Bioanalytical Laboratory (2nd Floor)

GLP compliant laboratory with 3,500 sq. ft. dedicated space for advanced bioanalytical services.

Services:
  • ✓Method development and validation
  • ✓Therapeutic drug monitoring (TDM) studies
  • ✓Pharmacokinetic (PK) services for BA/BE studies
  • ✓Complex assays: chiral, metabolites, proteins, hormones
Monthly Capacity
20,000 samples per month with dedicated QC and sample management teams

Advanced Instrumentation & Infrastructure

LC-MS/MS Platform
API 4500
ESI & APCI sources for small molecules, peptides, enantiomers
Picogram-level quantitation with minimal cycle time
Sample Storage
40,000+ Samples
-20°C and -70°C freezers with alarm systems
Fully controlled and monitored temperature management
Software Validation
21 CFR Part 11
All instrument software validated per international regulations
Ensures data integrity and compliance

Regulatory Approvals & Certifications

Analytical Services Laboratory
Regulatory Approvals:
✓ USFDA (FEI # 3019773458)
✓ DCA, CDSCO, DSIR, NABL
✓ GLP Certificate from DCA
ISO Certifications:
✓ ISO 45001:2018 (Occupational Health & Safety)
✓ ISO 14001:2015 (Environmental Management)
✓ ISO 50001:2011 (Energy Management)
Bioanalytical Laboratory
Global Regulatory Compliance:
✓US FDA
✓CDSCO (India)
✓ANVISA (Brazil)
✓MHRA (UK)
✓EMA (Europe)
✓GLP Certified

Cross-Functional Support Services

Integrated Formulation Division Support

Beyond analytical and bioanalytical services, Unit VII houses multiple cross-functional teams supporting the formulation division:

Business Development
Clinical Affairs
IP Management
Marketing & Sales
Pharmacovigilance
Quality Assurance