Preparation products of Yiling Pharma approved by FDA for launch in the US market

Yiling Pharmaceutical Co | September 19, 2020

Preparation products of Yiling Pharma approved by FDA for launch in the US market
Yiling Pharmaceutical Co., Ltd. announced on Friday that it had received the approvals of the Abbreviated New Drug Applications (ANDA) about Lisinopril Tablets and Acyclovir Capsules, from United States Food and Drug Administration (hereinafter referred to as the "FDA"), which were submitted by Yiling Wanzhou International Pharmaceutical Co., Ltd., one of the wholly-owned subsidiaries of Yiling Pharmaceutical Co., Ltd., meaning that these products are approved to be produced and sold in the U.S. market. The announcement showed that Lisinopril Tablets are mainly used for the treatment of essential hypertension (EH) and renal vascular hypertension (RVH) and were originally researched and developed by Astrazeneca and approved for launch in the United States in 1988. Currently its licensed producer is Alvogen Malta Operations Ltd., and the major manufacturers of its generic drugs are Casi, Ascent, and etc. in the United States. In addition to the originally researched and developed drugs, there are 11 producers for the generic drugs in China, among which, only one has passed the consistency evaluation. According to the IMS database, the saleroom of Lisinopril Tablets was about USD 131.39 million in the U.S. market in 2019.

Spotlight

One of the key roles of the generic and biosimilar medicines industry is specifically to promote
the widest possible access to affordable medicines with high quality, safety, and efficacy for
patients globally by introducing competition into the markets. Despite the many hurdles, the
generic medicines companies have clearly lived up to the challenges posed by the pandemic
as it is an industry that is quick to adapt and agile in manufacturing scale-up. During the
outbreak of COVID-19, this industry was providing most of the medicines needed in Intensive
Care Units to ventilate critically ill COVID patients. It is also providing most of the quality
medicines dispensed around the world, especially for increasingly prevalent chronic diseases
and is therefore a strong contributor to health outcomes globally.

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Spotlight

One of the key roles of the generic and biosimilar medicines industry is specifically to promote
the widest possible access to affordable medicines with high quality, safety, and efficacy for
patients globally by introducing competition into the markets. Despite the many hurdles, the
generic medicines companies have clearly lived up to the challenges posed by the pandemic
as it is an industry that is quick to adapt and agile in manufacturing scale-up. During the
outbreak of COVID-19, this industry was providing most of the medicines needed in Intensive
Care Units to ventilate critically ill COVID patients. It is also providing most of the quality
medicines dispensed around the world, especially for increasingly prevalent chronic diseases
and is therefore a strong contributor to health outcomes globally.