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Navesta Opens Sterile Mfg. Plant

Sri Lanka’s first EU-GMP, PIC/S compliant facility to enable exports of pharmaceuticals to international markets

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Sri Lanka-based Navesta Pharmaceuticals has opened the country’s first sterile pharmaceutical manufacturing plant in Horana. It also represents Sri Lanka’s first pharmaceutical facility that is compliant with EU Good Manufacturing Practices (EU-GMP) and Pharmaceutical Inspection Co-Operation Scheme (PIC/S), which will enable the company to export their products to most global markets that accepts these accreditations. Additionally, the facility is also equipped with the country’s first EU-GMP compliant A and B Grade Microbiology (MB) laboratory, capable of carrying out comprehensive, advanced in-house testing methodologies.

The company says it will primarily meet the local demand of 12 products in the penicillin category—dry powder injectables that were previously imported to the country.

“We have and will continue to generate numerous employment opportunities for Sri Lankans who specialize in pharmaceutical fields such as biochemistry, pharmacology, chemistry, pharmacy and engineering as well as Sri Lankans who are interested in developing this new industry further,” said Sanjaya Jayaratne, chairman, Navesta Pharmaceuticals. “Most importantly, Navesta’s ultimate aim is to provide a reliable, vertically integrated local supply chain, which will provide accessibility of high quality pharmaceuticals for our citizens. All our efforts surround the idea that we as a company, have a social responsibility to this generation and the next in providing our citizens better opportunities of a livelihood through our continual industry development, reinvestment in the communities, and empowerment of our employees to carry this vision forward for Sri Lanka.”

Navesta’s 40,000 square-foot manufacturing facility has a capacity to produce 50 million vials, saving millions in foreign expenditure for the country. Navesta Pharmaceuticals will expand the facility in the coming years to increase its production capacity by three-fold and contribute significantly to the Sri Lankan economy with exports. With the set-up of this facility, over 100 direct employment opportunities were created to include local graduates from chemistry, engineering, finance and pharmaceutical studies, while over 500 indirect employment opportunities were created through local home industries and ancillary services.

Navesta’s manufacturing facility houses 13 incubator chambers and 2 walk-in incubators which are Sri Lanka’s first 21 Code of Federal Regulations (CFR) compliant equipment sets. All test and measuring instruments that are used within the facility are calibrated up-to-date, from local and foreign agencies with ISO 17025 or ISO 9001 accreditations.

In 2015, the Government of Sri Lanka enacted the new National Medicinal Drugs Policy, which encouraged more local companies to explore the opportunity of manufacturing pharmaceutical products, to drive Sri Lanka towards the vision of becoming self-sufficient in pharmaceuticals by 2020.

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