USFDA Registered Laboratory

USFDA Registered Testing Laboratory India | FDA Compliance Testing

Auriga Research is a USFDA registered, NABL accredited, and WHO Pre-Qualified pharmaceutical testing laboratory. Three registered facilities, 110+ HPLCs, 9 LC-MS/MS systems, and 10,000+ validated methods supporting pharmaceutical manufacturers and exporters worldwide.

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USFDA Registered Labs

110+

HPLC Systems

10,000+

Validated Methods

Countries Served

What is USFDA Registration for Testing Labs?

USFDA registration means a testing laboratory is recognized by the United States Food and Drug Administration as a facility capable of generating test data accepted for US regulatory submissions. For pharmaceutical companies exporting to the US market, testing at a USFDA registered lab is essential for ANDA submissions, drug master file support, and FDA compliance documentation.

The significance for international buyers is direct: a Certificate of Analysis (COA) from a USFDA registered laboratory carries weight with US importers, FDA inspectors, and international procurement agencies. Combined with WHO Pre-Qualification, this dual recognition positions Auriga Research as a testing partner for pharmaceutical companies serving both US and global health markets.

Auriga's USFDA registration covers pharmaceutical finished product testing, raw material analysis, stability studies, and method validation — the core analytical requirements for drug application dossiers.

Pharmaceutical Testing Capabilities

Comprehensive pharmaceutical analytical testing under USFDA registration. Each capability is supported by validated methods, calibrated instruments, and documented SOPs meeting 21 CFR Part 11 data integrity requirements.

Stability Studies

ICH Q1A accelerated (6 months), real-time (2-3 years), stressed (30 working days), and ICH Q1B photostability testing.

Method Development & Validation

10,000+ customer-specific methods validated. ICH Q2(R1) compliant method validation for assay, impurity profiling, dissolution, and content uniformity.

Impurity Profiling

9 LC-MS/MS systems for trace-level impurity identification and quantification. Genotoxic impurity testing, elemental impurity analysis (ICH Q3D) via ICP-MS.

Dissolution Testing

Multi-station dissolution apparatus across all facilities. USP apparatus 1-4, in-vitro dissolution profiling, and f2 similarity factor calculations.

Microbiological Testing

Sterility testing (USP <71>), microbial limit testing (USP <61>/<62>), bacterial endotoxin testing (LAL method), environmental monitoring.

Raw Material & API Testing

Identity, purity, assay, and related substances testing for APIs, excipients, and packaging materials per pharmacopoeial monographs.

For International Pharmaceutical Buyers

If you are sourcing pharmaceutical products or APIs from India, Auriga Research provides the analytical assurance your supply chain requires. Our USFDA registration and WHO Pre-Qualification mean test reports are accepted without additional qualification by US importers and international procurement agencies.

USFDA Registered

Test reports accepted for US market regulatory submissions and import clearance.

WHO Pre-Qualified

Recognized by WHO Geneva for international pharmaceutical procurement programs.

NABL Accredited

13,216+ accredited test entries. ISO/IEC 17025:2017 compliant across 5 labs.

Pharmaceutical Testing

Full range of pharma analytical testing services.

NABL Accredited Lab

Our complete NABL accreditation scope across 5 labs.

Clinical Trials

Phase II-IV clinical research and bioequivalence studies.

CDSCO Approved Lab

Medical device and pharma regulatory testing.

Frequently Asked Questions

What does USFDA registered lab mean?

A USFDA registered laboratory is a testing facility registered with the United States Food and Drug Administration. Registration means the laboratory is recognized by the FDA for conducting pharmaceutical, food, or device testing. Test reports from USFDA registered labs are accepted by US regulatory authorities for drug application submissions, import clearances, and compliance verification.

Is Auriga Research USFDA registered?

Yes. Auriga Research holds USFDA registration at our Delhi and Bangalore laboratories. This registration enables us to provide testing reports accepted for ANDA (Abbreviated New Drug Application) submissions, drug master files, and pharmaceutical export documentation for the US market.

Which Auriga labs have USFDA registration?

Our Delhi (HQ), Manesar, and Bangalore laboratories hold USFDA registration. The Bangalore facility received USFDA approval in 2021. These facilities are equipped with 110+ HPLCs, 9 LC-MS/MS, and 5 ICP-MS systems for comprehensive pharmaceutical testing.

What pharma tests does Auriga perform under USFDA registration?

Under USFDA registration, Auriga performs stability studies (ICH Q1A/B), method development and validation (ICH Q2), impurity profiling, dissolution testing, microbiological testing (USP methods), raw material testing, and finished product analysis. Our 10,000+ validated methods cover most pharmacopoeial requirements.

Can Auriga support pharmaceutical exports to the USA?

Yes. Our USFDA registration, combined with WHO Pre-Qualification and NABL accreditation, means our test reports are accepted by US importers and regulatory authorities. We serve pharmaceutical exporters across 23 countries, with dedicated support for ANDA submissions and export quality documentation.

Does Auriga have WHO Pre-Qualification?

Yes. Auriga Research holds WHO Pre-Qualification (Geneva), recognizing our pharmaceutical testing capabilities for procurement programs by WHO, UNICEF, the Global Fund, and other international agencies. This makes us one of the few Indian labs with both USFDA registration and WHO PQ.

Need Pharmaceutical Testing from a USFDA Registered Lab?

Get a quote from Auriga Research — USFDA registered, WHO Pre-Qualified, NABL accredited. 110+ HPLCs, 10,000+ validated methods.

+91-7428116100 Request a Free Quote