EU-GMP & WHO-GMP Certified · Caring Every Life For Generations
T: +94 112 421 836 E: info@celogen.lk Mon–Sat · 9:00–17:00
✓ Manufacturing & Production

World-class manufacturing, built for scale

Celogen Lanka manufactures high-quality tablets, hard and soft gelatin capsules, suppositories, pessaries and sachets from a 10-acre EU GMP approved facility, with advanced technology, validated processes and quality controls built into every stage.

Our facility

Designed for precision, scale and compliance

Our integrated manufacturing facility brings together raw material storage, production blocks, packaging lines and quality control laboratories within a single, purpose-built pharmaceutical site.

Designed for operational efficiency, manufacturing flexibility and stringent regulatory compliance, the facility supports multiple solid dosage forms while maintaining quality controls at every stage

Every process is validated, every batch is traceable, and every product is released only after rigorous quality testing.

Production facility

Engineered for advanced pharmaceutical manufacturing

Located within the Kandy Industrial Park, Pallekele, Sri Lanka, our manufacturing facility spans 10 acres, with more than 14,000 square metres of built-up pharmaceutical infrastructure.

Designed for high-volume, multi-dosage manufacturing, the facility has an annual production capacity of approximately 1,500 metric tons and is supported by 11 production lines and 7 packing lines.

Our capabilities cover a wide range of solid dosage forms, including uncoated, film-coated, extended-release, sustained-release, prolonged-release and dispersible tablets; hard gelatin capsules with powders, pellets and extended-release pellets; soft gelatin capsules; suppositories, pessaries and sachets.**

10 Acre
Integrated Facility
14,000+ Sq. meters
Built Up Infrastructure
1,500 Metric Tons
Annual Production Capacity
11
Production lines
7
Packing lines

** Products marked with ‘**’ are in validation process; production to start soon.

Annual production capacity

Manufacturing at scale.

— 01 / Tablets
Uncoated, film-coated, ER/SR, dispersible
Tablets
6.16 BILLION
TABLET UNITS ANNUALLY

Uncoated, film-coated, modified-release and dispersible tablets.

527+
products in our tablet portfolio
— 02 / Soft Gel
Soft gelatin capsules & nutraceuticals
Soft Gel
289 MILLION
SOFTGEL UNITS ANNUALLY

Softgel and selected nutraceutical formulations

57+
products in our softgel portfolio
— 03 / Hard Gel
Hard gelatin capsules — powder & pellets
Hard Gel
1.04 BILLION
HARD CAPSULE UNITS ANNUALLY

Powder-filled, pellet-filled and modified-release capsules.

68+
products in our hard capsule portfolio
— 04 / Suppositories
Suppositories & pessaries
Suppositories
13 MILLION
SUPPOSITORY & PESSARY UNITS ANNUALLY

Specialised formulations for targeted therapeutic use.

15+
products in our suppository & pessary portfolio
Within the organization

Growing our people, strengthening our future

At Celogen Lanka, we believe that sustainable growth begins with our people. We are committed to creating an environment where employees can develop professionally, contribute meaningfully and grow alongside the organization.

Through structured training, internal and external development programmes, knowledge-sharing initiatives and employee engagement activities, we continuously invest in building skills, confidence and leadership across all functions.

Our culture is built on open communication, employee well-being, work-life balance, diversity, inclusion and recognition — creating a workplace where people feel valued, supported and motivated to perform at their best.

What we do

Integrated capabilities,
from raw materials to finished medicines

Warehouse and logistics

Climate-controlled storage for raw materials, packaging materials and finished goods, supported by barcode-level traceability across the supply chain.

Multi-form manufacturing

Manufacturing capabilities across tablets, hard and soft gelatin capsules, suppositories, pessaries and sachets, supported by dedicated production lines and robust cross-contamination controls.

In-house QC laboratories

Fully equipped chemical and microbiological laboratories with advanced analytical capabilities, including HPLC, GC, FTIR, dissolution testing and stability studies.

Packaging and serialisation

Blister, strip and bottle packaging lines with serialisation capabilities designed to support traceability and export-market requirements.

Utilities and infrastructure

Purified water systems, HVAC with HEPA filtration and critical process utilities engineered to support stringent regulatory compliance.

Quality & Innovation

Modern technologies and rigorous quality systems supporting product development, process improvement, continuous innovation and reliable batch release.

Product range

Dosage forms we manufacture

Across a growing portfolio of products, we manufacture a comprehensive range of solid dosage forms to meet diverse therapeutic needs.

Tablets

Tablets

Uncoated & film-coated tablets

Modified-Release Tablets

Modified-Release Tablets

Sustained, prolonged and extended-release formulations

Dispersible Tablets

Dispersible Tablets

Fast-dispersing formulations

Hard Gelatin Capsules

Hard Gelatin Capsules

Powder & Pellet filled capsules

ER Pellet Capsules

ER Pellet Capsules

Extended-release pellet formulations

Soft Gelatin Capsules

Soft Gelatin Capsules

Liquid & semi-solid fills formulations

Suppositories & Pessaries

Suppositories & Pessaries

Specialised dosage forms for targeted delivery

Sachets

Sachets

Granulated and powder formulations

Quality assurance

Quality and patient safety, embedded at every stage

At Celogen Lanka, patient safety is at the heart of everything we do. Guided by our commitment to caring for every life, across generations, our manufacturing operations are supported by stringent quality controls, validated processes and internationally aligned systems that ensure consistency, reliability and compliance at every stage.

High-grade stainless steel equipment
PLC-controlled automated machinery
Minimal human intervention
High accuracy and process repeatability
Batch traceability and documented quality system
Advanced laboratories equipped for chemical, microbiological and stability testing

The Quality Assurance and Quality Control teams work together to ensure that every product is manufactured, monitored, tested and released in accordance with applicable regulatory requirements and internal quality standards.

From raw material approval to finished product release, quality monitoring and surveillance remain integral to our operations — protecting patients, supporting healthcare professionals and strengthening trust one batch at a time.

QA · QC
Regularly audited by by NMRA Sri Lanka & European Medicines Agency and other international regulatory bodies
Certifications

International Certifications and Compliance

Celogen Lanka operates with a strong quality and regulatory foundation, supported by internationally recognized certifications, validated systems and advanced in-house analytical capabilities.

Our current portfolio includes 650+ registered and pipeline products, with 855+ SKUs across multiple dosage forms and therapeutic categories. Our fully equipped in-house laboratory is SLAB-accredited to ISO/IEC 17025:2017, with advanced analytical instruments including HPLC, ICP, UV spectrophotometry, gas chromatography, dissolution testers, FTIR and stability chambers.

APPROVED & CERTIFIED
EU GMP
European Union
European Union Good Manufacturing Practice approval for our pharmaceutical manufacturing facility.
WHO GMP / cGMP
NMRA · Sri Lanka
GMP approval issued by NMRA Sri Lanka, in line with WHO GMP standards.
PIC/S
Inspection Cooperation
Pharmaceutical Inspection Co-operation Scheme alignment supporting international GMP harmonisation.
ISO 9001:2015
Quality Management
Externally audited quality management system supporting consistent and reliable operations.
ISO 14001:2015
Environmental Management
Environmental management system supporting responsible and sustainable operations.
ISO 22000:2018
Food Safety Management
Food safety management system across applicable product lines and processes.
ISO 45001:2018
Occupational Health & Safety
Occupational health and safety management system supporting a safe and responsible workplace.
Regulatory Expansion
TGA
Australia
Therapeutic Goods Administration, Australia approval process in progress.
TPD
Health Canada
Therapeutic Products Directorate, Canada approval process in progress.
ANVISA
Brazil
Brazilian Health Regulatory Agency approval process in progress.
EAEU GMP
Eurasian Economic Union
Eurasian Economic Union GMP approval process in progress.