The latest official response from Huahai Pharmaceuticals has come after the recall

This month, the European Medicines Agency (EMA) announced that huahai Pharmaceuticals had accidentally discovered an impurity of nitrodymamine (NDMA) in some of the API preparations supplied to the European market, and that the EMA had decided to conduct an evaluation and investigation of the API, during which it had requested a recall of the pyrethroid preparations produced using the API. Several countries, including Germany, Italy, Finland, Austria and Japan, are also recalling preparations containing the company's raw materials for salatin.
Huahai Pharmaceuticals immediately issued a notice explaining that the company in the process of optimizing the production process of the raw materials of nitrate tan, under the unknown impurities, found and detected one of the unknown impurities is nitrodi methamphetamine (NDMA). It is investigated that the impurities are inherent impurities produced by the production process of the shoaltan, the content is very small, and the same production process used in employment is common. According to data based on animal experiments in the relevant scientific literature, the impurity is genetically toxic. Upon discovery of the situation, the Company immediately ceased commercial production of existing raw materials for salatin, kept the stocks separately, suspended all supplies and proactively informed customers and relevant regulatory authorities.
July 9, Beijing Novarma Pharmaceutical Co., Ltd. issued a statement saying that the company's anti-sartan drugs are made from raw materials made by Novartic's foreign companies and are not affected by the recall.
EMA said it was currently assessing the potential impact of NDMA on patients with the drug, and that the impurity could pose any risk to the patient, which the EMA would inform in the first place. At present, national registration regulations have not yet issued standards for the acceptable control limits of NDMA impurities produced in this production process.
After two consecutive announcements, on July 9, Huahai Pharmaceuticals also held an online investor's note on the unknown impurities of the raw material drug of pyridostaine found extremely trace genotoxic impurities, on a number of issues with investors to communicate and communicate, including the following points:1. Will the United States face a recall?
, several European countries have issued recalls, but whether the United States will recall is not yet known. At the network briefing, Huahai Pharmaceuticals said the company's process changes have been declared and officially approved, the company is in discussions with the U.S. FDA about relevant technical standards, it is not yet known whether it will face a U.S. recall.
, it is understood that Huahai Pharmaceuticals' salatin preparations were listed in the United States in 2015 with sales of $20.43 million in 2017. The company has voluntarily suspended market supplies pending official findings. Huahai Pharmaceutical Co., D.A. raw materials are mainly sold in North America, Europe, India, Russia and South America and other markets. In fiscal 2017, the sales value of its raw materials for satan was RMB328 million.2. How much will you lose?
from the point of view of direct losses, Huahai Pharmaceuticals may face the loss of customer returns and exchanges, as well as the manufacturers due to the recall of incidental liability. At present, the company is actively negotiating with customers to make effective judgments based on the recall of their preparations, preparations and stock of API, etc., and to negotiate solutions based on supply agreements, quality agreements and other relevant transaction documents with customers to minimize losses. It is not yet possible to accurately assess the impact of this event on current performance. However, the suspension of shipments will have an impact on the sale of semi-annual API.
addition to the suspension of production, the current production and operation of Huahai Pharmaceuticals is normal. Due to the different process conditions, the company does not detect the genotoxic impurities in any of its products other than the salatin.3. When will production resume?
as the main supplier of shatan and Puli in the global market, Huahai Pharmaceuticals has obvious advantages in product quality, production scale, customer cooperation and so on. It said it was actively engaged in proactive communication with regulators in various countries, including the FDA, and hoped to develop industry standards for NDMA impurities acceptable control limits in API as soon as possible.
, the company is optimizing existing production processes that avoid impurities in the production process. As no major changes to registration are involved, it is expected to resume production in a short period of time using the new process to ensure normal supply to the market. (Medical Economics)