On 18 September 2026, Shandong Xinhua Pharmaceutical Company Limited (“Xinhua Pharmaceutical”) announced that it has received a Drug Registration Certificate from China’s National Medical Products Administration (NMPA) for its Levocarnitine Oral Solution, marking formal approval for domestic production and sale.\n\nKey registration information includes: approval number National Medicine Zhunzi H20266018, certificate number 2026S03468, dosage form oral solution, specification 10 ml:1 g, and classification as a Class 4 chemical prescription drug. The case number CYHS2404213 traces back to an application first accepted by the NMPA’s Center for Drug Evaluation in December 2024.\n\nThe product is indicated for the treatment of primary systemic carnitine deficiency—characterised by recurrent Reye-like encephalopathy, hypoketogenic hypoglycaemia, cardiomyopathy, skeletal muscle hypotonia and growth failure—and for both short- and long-term management of secondary carnitine deficiency arising from inborn errors of metabolism. Clinical evidence cited by the company notes that carnitine supplementation can rapidly relieve disease symptoms, particularly cardiomyopathy.\n\nLevocarnitine Oral Solution is listed as a Category B medicine in the “National Drug Catalogue for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance (2025)”. According to publicly available hospital procurement data, sales of Levocarnitine Oral Solution in China’s public medical institutions reached approximately RMB400.00 million in 2025, underscoring the product’s commercial potential.\n\nManagement stated that the approval expands Xinhua Pharmaceutical’s oral metabolic modulator pipeline and is expected to strengthen the company’s competitive position in the domestic market. The company cautions, however, that pharmaceutical sales remain subject to policy changes, tendering dynamics and broader market conditions, which could affect actual commercial outcomes.