Finished Product Testing | All Dosage Forms | NABL Accredited | Auriga Research
Pharmaceutical finished product testing is the final quality verification before a drug product reaches patients. Auriga Research provides NABL-accredited finished product release testing for all dosage forms — oral solids, oral liquids, injectables and parenterals, topical and semi-solid preparations, inhalation products, transdermal drug delivery systems, ophthalmic and otic preparations, and rectal and vaginal products. Testing covers the complete pharmacopoeial specification (USP, IP, EP, BP, JP) including identity, assay, dissolution, content uniformity, related substances, microbial quality, and dosage-form-specific parameters.
For solid oral dosage forms, the package includes hardness, friability, disintegration, dissolution profiling (USP apparatus I and II), uniformity of dosage units, and stability-indicating assay and impurity methods. For parenteral products, we perform sterility testing (USP 71), bacterial endotoxin testing (USP 85), particulate matter (USP 788), pH, osmolality, and container closure integrity assessments. Topical products are evaluated for content uniformity, pH, viscosity, and in vitro release testing (IVRT). Inhalation products are tested for delivered dose uniformity and aerodynamic particle size by cascade impactor per USP 601 and EP 2.9.18.
We support both one-time product testing and ongoing batch-release programmes with scheduled turnaround commitments. Testing is delivered from Delhi HQ (Arbro Analytical Division), Manesar (USFDA Inspected), and Bangalore (USFDA Inspected), with the appropriate lab assigned by dosage form and regulatory submission requirement. All reports include certificate of analysis with raw-data traceability, pharmacopoeial compliance statements, and electronic delivery for direct integration with your quality management system. NABL-accredited (ISO/IEC 17025:2017) reports are accepted by CDSCO, USFDA, EMA, and PMDA without re-testing.
Eight Dosage Forms in Scope
Each card maps the dosage form to its key release tests, the governing pharmacopoeial reference, and the Auriga lab where testing is performed. All cards rendered at uniform height for direct comparison.
Oral Solids
Tablets · Capsules · Granules
Reference: USP, IP, EP, BP, JP
Labs: Delhi · Manesar · Bangalore
Oral Liquids
Syrups · Suspensions · Solutions
Reference: USP, IP, EP
Labs: Delhi · Manesar · Bangalore
Injectables & Parenterals
Liquid · Lyophilised · LVP/SVP
Reference: USP, IP, EP, ICH Q4B
Labs: Delhi · Bangalore
Topical & Semi-solids
Creams · Ointments · Gels · Lotions
Reference: USP, IP, EP
Labs: Delhi · Manesar · Bangalore
Inhalation Products
MDI · DPI · Nebulisation
Reference: USP 601, IP, EP 2.9.18
Labs: Manesar · Bangalore
Transdermal Drug Delivery Systems
Patches · Reservoir · Matrix
Reference: USP, IP, EP
Labs: Manesar
Ophthalmic & Otic Products
Drops · Ointments · Solutions
Reference: USP, IP, EP
Labs: Delhi · Bangalore
Rectal & Vaginal Products
Suppositories · Pessaries · Gels
Reference: USP, IP, EP
Labs: Delhi · Manesar
Project Timelines
Indicative TAT from sample receipt. Confirm exact timeline with your SPOC at quote stage based on dosage form, test scope, and sample queue.
| Service Type | Turnaround Time |
|---|---|
| Standard Finished Product Release Testing | 7 to 10 business days |
| Rush Testing (established product) | 3 to 5 business days |
| Sterile Product Testing (sterility + BET) | 14 to 21 business days |
| Inhalation / Transdermal Performance Tests | 10 to 14 business days |
| Batch-Release Programme (ongoing) | Custom schedule |
How It Works
Get a Quote
Share your product name, dosage form, batch number, and pharmacopoeial specification. Your SPOC confirms applicable tests, sample requirement, and committed TAT.
Collect and Send Your Sample
Prepare your sample per instructions confirmed by your SPOC at quote stage. Each sample is bar coded and registered in YLIMS on receipt.
Testing and QA Review
Your sample is tested under NABL-accredited conditions. All results pass through formal QA review including instrument log check, reference standard verification, and analyst sign-off.
Receive Your NABL Report
Your NABL-accredited report is delivered digitally within the committed TAT, formatted for CDSCO, USFDA, and regulatory submission. Track status via YLIMS.
Who Needs Finished Product Testing
- Pharma QC teams conducting release testing before batch disposition and commercial dispatch.
- Contract manufacturers conducting finished product testing on behalf of brand owners and marketing-authorisation holders.
- Generic developers generating finished product data for CDSCO or USFDA dossier submission.
- Importers requiring CDSCO shelf-sample testing for product registration or registration renewal.
- Regulatory affairs teams compiling product-quality dossier sections (Module 3) for CTD submission.
- CDMO clients running independent release testing alongside in-house QC for dual-vendor verification.
- Sterile-product manufacturers needing sterility, BET, and particulate matter under one accredited scope.
- Inhalation, transdermal, and ophthalmic product owners requiring specialised performance testing.
Why Auriga for Finished Product Testing
110+ HPLC Systems Across All Labs
Over 110 HPLC/UPLC systems distributed across Delhi, Manesar, and Bangalore. No backlog for routine release testing, even under multi-batch dispatch pressure.
All Dosage Forms Under NABL Scope
Oral solids, oral liquids, injectables, topicals, inhalation, transdermal, ophthalmic, and rectal/vaginal products — all under one accredited NABL (ISO/IEC 17025:2017) scope. One vendor, one scope letter.
USFDA Inspected at Manesar and Bangalore
QC release data generated at Manesar and Bangalore — both USFDA Inspected — is accepted in USFDA dossier submissions without re-testing.
NABL Reports Accepted by CDSCO, USFDA, EMA
NABL accredited (ISO/IEC 17025:2017) certificates of analysis accepted by CDSCO, USFDA, EMA, and PMDA without re-testing. Formatted for direct dossier inclusion.
Sterility, BET, and Particulate Matter In-House
USP 71 sterility, USP 85 BET (gel-clot, KTA, KCA, rFC), and USP 788 particulate matter testing in a dedicated microbiological suite. Sterile-product workflow under one roof.
Batch-Release Programmes with Scheduled TAT
Ongoing batch-release contracts with committed turnaround windows. Multi-batch capacity, electronic CoA delivery, and direct integration with your QMS workflow.
5+
NABL Accredited Labs
5 Cities
Delhi · Manesar · Bahadurgarh · Baddi · Bangalore
12,000+
Clients Served
1985
Arbro Group · Auriga Research
Pharmacopoeial References
- • USP — United States Pharmacopoeia, including USP <71> (sterility), <85> (BET), <601> (inhalation), <788> (particulate matter), <51> (preservative efficacy).
- • IP — Indian Pharmacopoeia, including IP 2.2.3 (BET) and dosage-form-specific monographs.
- • EP — European Pharmacopoeia, including EP 2.6.14 (BET) and EP 2.9.18 (inhalation).
- • BP / JP — British Pharmacopoeia and Japanese Pharmacopoeia for global submission support.
- • ICH Q6A — Specifications for new drug substances and new drug products.
- • ICH Q4B — Pharmacopoeial harmonisation framework.