Take Ling Pharmaceutical's first sustained-release preparation to go abroad or pass the consistency evaluation for the first time
Source: Pharmaceutical Network
On the evening of October 28, Yiling Pharmaceuticals issued an announcement that the company ’s wholly-owned subsidiary, Lingwanzhou International Pharmaceuticals, had applied to the FDA for a brief application for the new drug "felodipine sustained-release tablets". This product is the third variety that Ling Pharmaceutical has obtained the FDA approval number, and is the company's first exported sustained-release preparation.
Felodipine sustained-release tablets are dihydropyridine calcium channel antagonists used to treat hypertension (can be used alone or in combination with other antihypertensive drugs). According to the MINET database, the overall market of terminal felodipine in Chinese public medical institutions in 2017 was 2.023 billion yuan, of which the sales of sustained-release tablets were 1.634 billion yuan.
According to the MINET MID drug index comprehensive database, including the original research manufacturer AstraZeneca, there are currently 6 manufacturers that have approved the production of felodipine sustained-release tablets. Go public. From the perspective of product competition, the former researcher AstraZeneca ranked first with a market share of more than 80%, and the products of Changzhou Siyao Pharmaceuticals followed closely with a market share of 8.77%.
According to the announcement, felodipine sustained-release tablets of Yiling Pharmaceuticals are the third approval number approved by the company in the United States and the first approval number for sustained-release preparations. In addition, although Felodipine sustained-release tablets have not been listed in the country, the company is about to carry out domestic registration work. Up to now, no such products have passed the consistency evaluation in the country, and no such products are in the consistency evaluation application stage. It is expected to achieve overtaking in corners by reporting to the country from abroad, and become the first enterprise that has passed the consistency evaluation.
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