Wanbury Limited has announced the expansion of its regulatory submissions for active pharmaceutical ingredients (APIs) across key international markets, strengthening its global growth strategy.
The company has submitted Drug Master Files (DMFs) for Diphenhydramine HCl in Malaysia and Singapore. It has also initiated regulatory filings for Paroxetine HCl to explore new market opportunities in South Korea and Latin America.
In a further regulatory milestone, Wanbury received the formal audit report from the Ministry of Food and Drug Safety (MFDS), commonly known as the Korea FDA, for its Patalganga manufacturing facility. The report recorded zero observations following an inspection conducted in April 2026.
The company stated that the regulatory filings and successful audit outcome reinforce its commitment to expanding its international API footprint and maintaining high-quality manufacturing standards across global markets.