Huahai Pharmaceutical

Huahai Pharmaceutical, formally Zhejiang Huahai Pharmaceutical Co., Ltd., is a Chinese pharmaceutical company founded in 1989 and headquartered in Linhai, Zhejiang. It is a publicly traded company in China. Its business spans active pharmaceutical ingredients (APIs), finished pharmaceutical formulations, and contract development and manufacturing services (CDMO). The company serves domestic and international pharmaceutical markets. Its product and service areas include generic medicines and pharmaceutical ingredients, alongside manufacturing and development capabilities for customers. The supplied evidence identifies Huahai as a CDMO brand, while the company’s official website was returning a notice that the site had been suspended when checked. This dossier therefore does not rely on that site for detailed current product, leadership, or market claims.

Huahai Pharmaceutical is a Chinese pharmaceutical company established in 1989. It developed as a manufacturer in the pharmaceutical sector, with business spanning active pharmaceutical ingredients and finished formulations, as well as contract development and manufacturing services. The company is headquartered in Linhai, Zhejiang, and is publicly traded in China. Huahai serves pharmaceutical customers in China and international markets. Its combination of product manufacturing and contract services places it across both the supply of medicines and the pharmaceutical development and production chain. The evidence supplied for this dossier specifically describes it as a CDMO brand, but provides no detail on particular customer programs, facilities, or service capabilities. The company’s official website, https://huahai.com, displayed a notice stating that the site had been suspended by its administrator. As a result, that source could not substantiate current leadership, product catalogues, company announcements, or other present-day operating details. No specific dated corporate turning points are included here beyond the company’s establishment, as the provided evidence does not document them.

• 1989

  Company established

A Chinese pharmaceutical manufacturer and CDMO serving domestic and international markets.

• Active pharmaceutical ingredients

  A core pharmaceutical manufacturing category associated with the company.

• Finished formulations

  Finished pharmaceutical medicines.

• CDMO services

  Contract development and manufacturing services; the supplied seed evidence labels Huahai as a CDMO brand.

• 2018

  NDMA impurity detected in valsartan API, triggering global recalls and import restrictions

  In 2018, NDMA was detected in valsartan active pharmaceutical ingredient (API) produced by Huahai Pharmaceutical. Multiple countries initiated recalls of affected medicines, and questions were raised about the timing of disclosure and recalls in China. The company halted production and described its risk assessment and communications with regulators; the United States and Europe subsequently imposed restrictions on products linked to its Chuannan production site. The incident was confined to the affected API and facility.

  Source

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• 2020-08-20

  Hua Hai Pharmaceutical wins bids for three products in China's third national drug procurement[5]华海药业在第三批国家药品集中采购中三款产品中标finance.sina.com.cn

  Reported: 2020-08-20

  Hua Hai Pharmaceutical confirmed that its three products—valsartan tablets, olanzapine orally disintegrating tablets, and sertraline hydrochloride tablets—won bids in China's third national drug procurement. The article reported a disclosed valsartan tablet bid price of 0.219 yuan per tablet, down 70.2%; the company said it could not disclose its winning prices.

1. 1Official websitehuahai.com
2. 2NDMA impurity detected in valsartan API, triggering global recalls and import restrictionsthepaper.cn
3. 3NDMA impurity detected in valsartan API, triggering global recalls and import restrictionsthepaper.cn
4. 4NDMA impurity detected in valsartan API, triggering global recalls and import restrictionsyicai.com
5. 5华海药业在第三批国家药品集中采购中三款产品中标finance.sina.com.cn