Manesar Lab · NABL TC-15532 · USFDA Inspected · DCGI Approved · ISO 9001 · AERB

Pharmaceutical Testing Laboratory in Gurugram | NABL and USFDA Inspected

The Gurugram (Manesar) Pharmaceutical Testing Laboratory at IMT Manesar provides USFDA-inspected and DCGI-approved pharmaceutical testing under NABL accreditation (ISO/IEC 17025:2017, Certificate TC-15532). DCGI approved since 1995, the Manesar facility supports stability, assay, dissolution, microbiological limits, particle size analysis (Malvern Mastersizer 3000), and Franz diffusion cell studies, with an integrated Clinical Research Division on the same site for BA / BE, PK / PD, HRIPT, and SPF in-vivo claim substantiation.

Get a Quote for Gurugram Pharma Testing Clinical Trial Enquiries Call +91 74281 16100

Manesar Lab Address

Plot 136, Sector 5, IMT Manesar, Gurugram, Haryana 122052

NABL Certificate: NABL TC-15532

Validity: Valid until February 2029

Phone: +91 74281 16100

Email: [email protected]

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What the Manesar Lab Tests for Pharmaceuticals

Six testing categories confirmed in the Manesar NABL TC-15532 scope (13 pharmaceutical entries plus 6 cosmetics and essential oils, and 2 radiological water parameters).

Assay & Potency

Quantitative assay of active pharmaceutical ingredients in finished dosage forms under NABL TC-15532 pharmaceutical scope (13 entries).

Stability Testing

Real-time and accelerated stability studies under ICH-aligned conditions for finished pharmaceutical formulations.

Dissolution & Disintegration

USP apparatus dissolution and disintegration testing for solid and semi-solid dosage forms under NABL-accredited conditions.

Microbiological Limits

Total aerobic microbial count, total yeast and mould, and pathogen testing per USP and IP for non-sterile pharmaceutical products.

Cosmetics & Essential Oils

Physicochemical testing for cosmetics and essential oils (6 parameters confirmed in TC-15532 scope) at the same facility.

Radiological — Water

Alpha and Beta emitter analysis in water samples (2 parameters confirmed in TC-15532 scope) for regulatory and operational reporting.

Co-located CRD: The Manesar facility hosts a Clinical Research Division on the same site for BA / BE studies, bioanalytical testing, PK / PD studies, HRIPT, and SPF in-vivo claim substantiation per ISO 24444. Explore clinical research services at Manesar →

Key Parameters Tested

Six of the most-requested analytical parameters at the Manesar pharmaceutical testing lab.

Assay & Potency

Quantitative assay of active pharmaceutical ingredients by HPLC, UPLC, UV, and titrimetric methods against pharmacopoeial limits.

Dissolution

USP apparatus dissolution testing and profiling for solid and semi-solid dosage forms under NABL-accredited conditions.

Stability (ICH Conditions)

Real-time and accelerated stability studies under ICH-aligned controlled temperature and humidity protocols.

Particle Size (Malvern Mastersizer 3000)

Laser diffraction particle size distribution from 0.01 to 3500 µm — confirmed instrument capability at the Manesar facility.

Franz Diffusion Cell

In-vitro permeation and release studies with 7 stations and synthetic membranes — confirmed setup at the Manesar facility for topical and transdermal formulations.

Microbiological Limits

TPC, yeast and mould, and pathogen testing per USP and IP for non-sterile pharmaceutical products.

Why Use the Gurugram (Manesar) Lab for Pharmaceutical Testing

Six reasons pharmaceutical companies across the Gurugram-NCR corridor and international markets choose the Manesar lab.

USFDA Inspected Facility

US FDA-inspected pharmaceutical testing lab. Reports accepted by US FDA, ANDA / NDA filers, US importers, and international regulatory bodies.

DCGI Approved Since 1995

Drugs Controller General of India (DCGI) approval continuously since 1995, supporting CDSCO submissions and Indian pharmaceutical filings.

USFDA-Backed QC Reports

Ideal for pharmaceutical companies needing USFDA-inspected pharmaceutical QC reports, contract manufacturer due diligence, and US market submissions.

Co-located Clinical Research Division

The Manesar facility houses a Clinical Research Division on the same site — BA / BE, bioanalytical, PK / PD, HRIPT, and SPF in-vivo studies available alongside analytical testing.

Gurugram NCR Pharma Corridor

Strategically located inside IMT Manesar, serving the Gurugram-NCR pharmaceutical manufacturing corridor with local sample logistics.

AERB + ISO 9001:2015 Quality Stack

NABL TC-15532, Atomic Energy Regulatory Board (AERB) recognition for radiological water, and ISO 9001:2015 quality management — a complete pharmaceutical quality stack.

How It Works

Four steps from initial enquiry to digital report. Standard TAT 5 to 7 working days. Express testing available.

01

Contact the SPOC

Call your single point of contact at +91 74281 16100 to confirm the test scope, applicable pharmacopoeial standard, and sample submission details.

02

IMT Manesar Drop Off or Courier

Drop the sample at the IMT Manesar address or send by pre-approved courier. Each sample is bar coded on receipt and registered in YLIMS.

03

Testing Under NABL & USFDA Conditions

Testing is conducted under NABL-accredited conditions (TC-15532) and USFDA-inspected protocols with in-process QA checks against the applicable standard.

04

Report via YLIMS

The digital report is issued and accessible via YLIMS. Standard TAT 5 to 7 working days. Express testing available for time-critical batches.

Accreditations and Approvals

Six credentials held at the Manesar facility supporting pharmaceutical testing.

NABL TC-15532 logo
NABL TC-15532

ISO/IEC 17025:2017, Valid Feb 2029

USFDA Inspected logo
USFDA Inspected

US FDA inspected pharmaceutical testing facility

DCGI Approved
DCGI Approved

Drugs Controller General of India approved since 1995

ISO 9001:2015 logo
ISO 9001:2015

Quality management system certified

AERB
AERB

Atomic Energy Regulatory Board recognised

Form-37
Form-37

Pharmaceutical drug testing licence

Get a Quote for Gurugram Pharma Testing

NABL TC-15532 accredited pharmaceutical testing with USFDA Inspected and DCGI approved (since 1995) protocols at IMT Manesar. Standard TAT 5 to 7 working days. Express options available.

+91-7428116100 Get a Quote for Gurugram Pharma Testing

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