Our regulatory expertise extends to supporting IND, NDA, ANDA, DMF, and MA filings, ensuring a smooth pathway for global market access with comprehensive quality management systems.
At Shilpa Pharma Lifesciences Limited, we are dedicated to maintaining the highest levels of quality and compliance, ensuring that every product we develop meets and exceeds international regulatory expectations. Our comprehensive approach spans from development to manufacturing, with robust systems ensuring global market readiness.
United States
Europe
European Union
Canada
Brazil
Australia
Global
Subject to internal validation
State-of-the-art quality control laboratories with HPLC, UPLC, LC-MS, GC-MS, XRPD, and FTIR etc.
Analytical method development, validation, and transfer following ICH Q2 guidelines
Comprehensive stability studies under ICH Q1A(R2) conditions for global regulatory submissions
In-depth impurity profiling, elemental analysis, and microbiological testing capabilities
Preparation of Drug Master Files (DMFs), Common Technical Documents (CTD/eCTD), and Chemistry, Manufacturing & Controls (CMC) dossiers
Support for GMP audits, regulatory inspections, and customer quality assurance programs
Expertise in life-cycle management and post-approval regulatory compliance
Supporting IND, NDA, ANDA, DMF, and MA filings for smooth pathway to global markets
Contact Us today to learn more about our quality and regulatory capabilities!
We uphold stringent Quality Management Systems (QMS) with full compliance to global regulatory standards—including USFDA, EMA, WHO, ANVISA, CDSCO, ICH, Saudi GMP, and more. Accredited across multiple divisions and fully certified, we commit to data integrity and best-in-class operational excellence.
Certification | Scope |
|---|---|
| ISO 14001:2015 | Environmental Management System |
| ISO 45001:2018 | Occupational Health & Safety Management System |
| ISO 50001:2018 | Energy Management System |
| SA 8000 | Social Accountability — ethical labour and workplace standards |
| NABL | National Accreditation Board for Testing & Calibration Laboratories |
Our labs are outfitted with advanced instrumentation and environments for rigorous quality control:
HPLC (UV/FLD/DAD), GC (FID), LC-MS, FTIR, particle counters, electrophoresis units, PCR/RT-PCR systems, ELISA, Karl Fischer, TOC, microscopes, stability chambers (-20 °C to 40 °C/high humidity), and more
GLP-compliant bioanalytical and QC labs, with appropriate classified zones, controlled temperature and humidity, and wide-ranging analytical capabilities—handling chemical, molecular biology, microbiology, bioassay, and stability-DP testing
Labs regularly audited and approved by USFDA, CDSCO, ANVISA, EMA, MHRA, enhancing global trust for developmental and submission purposes
Comprehensive QA/QC systems and documentation packages ready for regulatory audits
Comprehensive CoAs and validated analytical reports meeting international standards
Verified stability and method validation dossiers for regulatory submissions
Secure, digitally compliant data and training records (Docuzen, Eduzen, Qualzen)
Our comprehensive quality systems and global accreditations ensure that every product we develop and manufacture meets the highest standards of quality, safety, and efficacy. With zero tolerance for data integrity breaches and robust digital systems, we provide our partners with complete confidence in our quality assurance processes.
World-Class Quality Standards
USFDA Approved • WHO GMP Certified • NABL Accredited • ISO Certified • 21 CFR Part 11 Compliant
Quality in pharmaceutical manufacturing is not a department — it is a design constraint. Shilpa Medicare’s facilities are designed to satisfy the most demanding regulator that will inspect them, not the minimum applicable standard. That approach costs more to build and more to operate. It is also the only approach that allows a manufacturer to supply the United States, the European Union, Japan and India from the same quality system. The company has filed 290 Drug Master Files globally and holds over 500 regulatory filings in total.
Authority | Region | Facilities Approved |
|---|---|---|
| US FDA | United States | API Unit I (Raichur), API Unit II (Raichur), Unit VI (Dabaspet, Bengaluru), Unit VII (Nacharam, Hyderabad) |
| EMA / EU-GMP | European Union | API Units I & II, Unit IV (Jadcherla), Unit VI, Unit VII, Shilpa Biologicals (Dharwad) |
| EDQM | Europe — CEP | API Units I & II |
| UK MHRA | United Kingdom | Unit VI, Unit VII |
| PMDA | Japan | API Units I & II, Shilpa Biocare (Kadechur) |
| MFDS / KFDA | South Korea | API Units I & II, Shilpa Biocare |
| TGA | Australia | API Units I & II, Unit IV, Unit VI |
| ANVISA | Brazil | API Units I & II, Unit IV |
| COFEPRIS | Mexico | API Units I & II, Unit IV |
| Health Canada | Canada | API Units I & II, Unit IV, Shilpa Biocare |
| SFDA | Saudi Arabia | Unit VI, Unit IV |
| SAHPRA | South Africa | Unit IV |
| DIGEMID | Peru | Unit IV |
| Oman MoH | Oman | Shilpa Biologicals (Dharwad) |
| EAEU / Belarus MoH | Russia, Belarus, Kazakhstan, Kyrgyzstan, Armenia | API Units I & II, Unit IV, Unit VII, Shilpa Biocare |
| WHO-GMP | Global | API Unit II, Unit IV, Unit VI, Shilpa Biocare |
| CDSCO | India | All Indian facilities |
Filing Type | Count |
|---|---|
| Drug Master Files filed globally | 290 (37 added in FY2026) |
| — US FDA (USDMF) | 55 |
| — European Union / EMEA | 62 |
| — GCC & rest of world | 37 |
| — MFDS South Korea | 26 |
| — Canada | 22 |
| — TGA Australia | 18 |
| — China | 14 |
| — PMDA Japan | 12 |
| — Russia | 8 |
| — New Zealand | 8 |
| — ANVISA Brazil | 7 |
| Certificates of Suitability (CEP) | 29 filed, 26 approved |
| European ASMF / EDMF | 30 filed, 24 approved |
| Filings and approvals in which Shilpa Medicare's DMFs or dossiers are referenced, worldwide | 499 |
| Total regulatory filings | 500+ |
| New approvals received FY2026 | 50+ |
Date | Facility | Authority | Outcome |
|---|---|---|---|
| Sept 2024 | Unit VII, Nacharam | EMA (Austria) | Passed — EU-GMP certificate awarded December 2024 |
| Oct 2024 | Unit IV & Unit VII | Belarus MoH (EAEU) | GMP approval covering Belarus, Russia, Kazakhstan, Kyrgyzstan, Armenia |
| Oct 2024 | Unit VI, Dabaspet | US FDA | EIR received, VAI classification, no Form 483 observations |
| Feb 2025 | Shilpa Biologicals, Dharwad | EU competent authority | Closed with zero observations → EU-GMP |
| Mar 2025 | Shilpa Biologicals Unit 2 | US FDA | Zero observations |
| Mar 2025 | API Unit I, Raichur | US FDA | 1 procedural observation → EIR received May 2025, VAI classification |
| Mar 2025 | Unit VI, Dabaspet | Fimea (Finland) for EMA | Minor observations → EU-GMP certificate May 2025 for ODF and TDS |
| FY2025 | API Unit II, Raichur | US FDA | Zero observations — second consecutive zero-observation inspection |
| Jul 2025 | API Unit I, Raichur | ANVISA | Cleared |
| Jul 2025 | Unit VI, Dabaspet | SFDA Saudi Arabia | GMP certification, zero observations |
| May 2026 | Unit VI, Dabaspet | US FDA (pre-approval inspection) | 5 procedural observations, no repeats, no data integrity findings; VAI status maintained |
Shilpa Medicare publishes inspection outcomes as a matter of transparency. Full inspection history is available to qualified customers under confidentiality agreement.
