Natco faces double whammy, falling profit, FDA plant violations

祸不单行!印度制药公司Natco Pharma业绩下滑,原料药工厂又遭FDA调查

2019-08-13 18:10:00 FiercePharma

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India’s Natco Pharma, which has seen a substantial hit to its profits, says it is looking to China and emerging markets for future growth as headwinds in the U.S. slow revenues there. Those headwinds involve the deteriorating pricing market for generics, but as the drugmaker disclosed today, they also involve some issues raised by U.S. regulators.  Natco in a filing (PDF) today said that an inspection of its API manufacturing facility near Hyderabad was completed Friday, and the FDA issued a Form 483 with six observations. The company said it is responding and believes it can deal with the issues promptly.  While not giving specifics, the drugmaker pointed out none of the issues involved data integrity. It did say some involved lapses in the quality control lab, as well in the microbiology lab. There also were issues with supplier and service provider agreements, employee training and revalidation and approvals for alternate suppliers.  "The company believes that none of the observations are related to data integrity and that all the observations can be addressed within a short period of time,” Natco said in a public filing. While it sees issues at the Mekaguda plant, it has been making investments in a plant in Kothur in anticipation of approval of its generic version of Celgene’s Revlimid. According to a transcript of a call with analysts, Natco CEO V C Nannapaneni said the FDA has inspected the plant, and the company also is answering questions on its ANDA. “I think, in the next few months, we're expecting the approval," Nannapaneni, told analysts.  That should be a boost to the company’s U.S. business, which is suffering. The company last week reported earnings in which revenues were off 10% and profit was down nearly 21%. Nannapaneni told The Economic Times that the company has been making investments to build its business in Asia and Australia to offset the declines in the U.S market.  “As we continually balance our portfolio of products and growth in the U.S., we expect majority of revenue to be coming from non-U.S. markets," Nannapaneni told the publication.  
印度制药公司 Natco Pharma 表示,由于美国收入增长放缓,该公司预计未来的增长将来自中国和新兴市场。这些不利因素包括仿制药定价市场的恶化,但正如制药商今天披露的那样,它们也涉及美国监管机构提出的一些问题。 Natco 今天在一份文件( PDF )中说,周五完成了对其位于海得拉巴(Hyderabad)附近的原料药(API)生产设施的检查, FDA 发布了一份483表格,其中有6个观察结果。该公司表示正在作出回应,并相信它能够迅速处理这些问题。 虽然没有给出具体细节,但制药商指出,没有一个问题涉及数据完整性。它确实说,质量控制实验室和微生物学实验室的一些失误。供应商和服务供应商协议、雇员培训和重新验证以及替代供应商的批准也存在问题。 Natco 在一份公开文件中表示:“该公司认为,这些观察结果都与数据完整性无关,所有观察结果都可以在短期内得到解决。” 尽管它看到了 Mekaguda 工厂的问题,但它一直在投资 Kothur 的一家工厂,以期待批准新基(Celgene)的 Revlimed 的通用版本。根据一份与分析师通话的记录, Natco 首席执行官 V C Nannapani 表示, FDA 已经检查了该工厂,该公司也在回答有关其 ANDA 的问题。 “我认为,在未来几个月内,我们预计会获得批准,”南纳帕尼对分析师表示。 这应该会提振该公司的美国业务,因为美国业务正遭受重创。该公司上周公布收益报告,收入下降10%,利润下降近21%。南纳帕尼对《经济时报》表示,该公司一直在进行投资,以在亚洲和澳大利亚建立业务,以抵消美国经济下滑的影响。美国市场. “在我们不断平衡产品组合和美国市场增长的同时,我们预计大部分收入将来自非美国市场,”南纳帕尼告诉该出版物。

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