Manufacturing & Quality

Two units. One campus. One quality standard. Both of our WHO-GMP certified facilities are located at the Brahmaputra Industrial Park in Amingaon, Guwahati — on adjacent plots within the same industrial estate.

Combined built-up area	Installed capacity	Production assets
~22,000 sq.m.	700 million units / year	~140 equipment

Unit 1 — Amingaon (Oral Solid Dosage)

Our primary oral solid dosage facility — tablets, film-coated tablets, and hard-gelatin capsules — with a segregated beta-lactam block operated under independent HVAC and effluent systems.

Address

Plot 12, Brahmaputra Industrial Park, Amingaon, Guwahati – 781031

Commissioned

2005

Built-up area

~13,500 sq.m.

Primary dosage forms

Tablets, film-coated tablets, hard-gelatin capsules

Annual capacity

500M tablets · 150M capsules

Segregated blocks

Beta-lactam wing (independent HVAC and effluent)

Certifications

WHO-GMP · ISO 9001:2015 · ISO 14001:2015

Unit 2 — Amingaon (Liquid Orals & Semi-solids)

Adjacent to Unit 1 on the same industrial park, this facility handles liquid oral formulations — syrups, dry syrups, suspensions — and non-sterile semi-solid preparations such as ointments and creams.

Address

Plot 14, Brahmaputra Industrial Park, Amingaon, Guwahati – 781031

Commissioned

2011

Built-up area

~8,500 sq.m.

Primary dosage forms

Syrups, dry syrups, oral suspensions, ointments, creams

Annual capacity

42M bottles (pooled) · 6M tubes (semi-solids)

Line count

2 liquid fill lines · 1 dry-syrup line · 1 semi-solid line

Certifications

WHO-GMP · ISO 9001:2015

Quality Systems

Both units operate under a unified Quality Management System aligned with WHO-GMP, ICH Q7/Q9/Q10 guidance, and ISO 9001:2015. Each batch is released under the signature of a Qualified Person following in-process and finished-product testing against pharmacopoeial specifications.

Area	Summary
QA / QC laboratories	Shared analytical laboratory serving both units, equipped with HPLC systems, dissolution apparatus, Karl Fischer titrators, FT-IR, UV-visible spectrophotometers, and walk-in stability chambers under ICH Q1A conditions.
Calibration & qualification	A central calibration master plan covers ~140 production and laboratory instruments across both units, with periodic re-qualification under our Validation Master Plan and documented change control.
Documentation & audit readiness	Batch manufacturing records, deviation logs, CAPA, change control, and training records are maintained under a documented retention policy, with regular internal audits and annual management reviews.

Regulatory Approvals

Both units are regulated and inspected by the relevant national authority. Our export registrations are maintained in partnership with our country representatives.

Authority	Applicability
Central Drugs Standard Control Organisation (CDSCO), India	Both units
Assam State Drug Controller	Both units
WHO-GMP (Geneva format)	Unit 1 & Unit 2
Department of Drug Administration, Nepal	Registered exporter
Pharmacy & Poisons Board, Kenya	Registered exporter
EFDA, Ethiopia	Registered exporter
NMRA, Sri Lanka	Registered exporter
FDA, Myanmar	Registered exporter

Environment, Health & Safety

Our Amingaon campus operates a common effluent treatment plant sized for both units, with primary and secondary treatment stages before discharge into the estate-level sewer. Unit 1 has installed a 200 kWp rooftop solar array which meets approximately 28% of the campus daytime electrical demand. We are progressively transitioning to water-based coating systems in our film-coating operations and have reduced single-use plastics in our secondary packaging lines by 42% since 2021.

Our Environment, Health & Safety committee meets monthly, with a cross-unit internal audit conducted each quarter. We maintain ISO 14001:2015 certification at Unit 1, and Unit 2 is currently in the final phase of certification review.