Your Trusted Partner in End‑to‑End Pharmaceutical Development & Manufacturing

From formulation to packaging, Synokem delivers world‑class CDMO solutions that ensure speed, quality, and compliance — empowering pharma and biotech companies to bring life‑changing medicines to market faster.

INTERNATIONAL BUSINESSES

Expanding Horizons, Enabling Health Worldwide

Since it started its export operation in 2015 with a CDDA (Sri Lanka FDA authority) license, Synokem Pharmaceutical Limited has been developing its global reach in various continents in the past seven years. We have expanded into other markets by securing international regulatory approvals and passing various country-specific audits successfully. We continue to focus on conducting new stringent regulatory authority (SRA) audits with an objective to enter regulated markets.

REGULATORY & INNOVATION

With over 44 years of industry experience, Synokem combines scientific expertise, state-of-the-art R&D facilities, and heritage to deliver a vision-driven portfolio of off-patent molecules to the global healthcare sector.

Pre-audits planned for regulated and strict markets to facilitate entry in unexplored markets.
Enhanced systems to enable preparation for regulated market qualifications.
2026 Goal: Become PIC/s audit compliant.

GLOBAL PRESENCE

Serving markets across 6 continents with regulatory excellence

0+
Countries
0+
Registration Certificates
0+
Filed Dossiers
0+
Total Products
Africa

8 Countries

Kenya, Nigeria, Uganda, Sudan, Zambia, Botswana, DR Congo, Ghana

Upcoming: Tanzania, Ethiopia

LATAM

4 Countries

Ecuador, Guatemala, Costa Rica, Venezuela

Middle East

2 Countries

Yemen, Kurdistan

CIS

5 Countries

Uzbekistan, Kyrgyzstan, Tajikistan, Turkmenistan, Mongolia

SAARC

4 Countries

Afghanistan, Bhutan, Nepal, Sri Lanka

South-East Asia

3 Countries

Myanmar, Philippines, Cambodia

KEY APPROVALS

Regulatory excellence across global markets including:

KENYAPPB
SUDANNMPB
PHILIPPINESPFDA
UGANDANDA
YEMENSBDM
NIGERIANAFDAC
NEPALDDA
SRI LANKACDDA

OUR UNIQUE VALUE PROPOSITION

Regulatory Expertise

CTD dossiers, clinical trials, BE studies, WHO-GMP/ICH compliance, CQA audits, and quality agreements.

Customisation

Solutions customized to market requirements but keeping international standards.

Delivery

Timely delivery with strong commitment follow-through.

Quality

Adhering to specified standards of quality.

Innovation

Fully equipped R&D department, formulation development, microbiological & analytical testing, stability studies.

Recent Regulatory Developments (2025/26)

Country audit filings under preparation for Uzbekistan and Kyrgyzstan.

Application for EAEU audit by CIS central authority underway.