Huahai Pharmaceutical

Zhejiang Huahai Pharmaceutical Co., Ltd. was founded in 1989 and is headquartered in Zhejiang, China. It is a pharmaceutical enterprise integrating chemical drugs, biologics, pharmaceutical packaging and trade distribution, with product lines led by cardiovascular, psychiatric, neurological and anti-infective categories, and extending into endocrine and metabolic, autoimmune and antitumor therapeutic areas. Its sales cover nearly 200 countries and regions, and it has more than 8,000 employees. The company states it has built a national-level enterprise technology center, academician workstation, postdoctoral research workstation and provincial key enterprise research institute, and is listed among China's top 100 pharmaceutical industry enterprises. It describes four "firsts" in China's pharmaceutical internationalization: first Chinese pharmaceutical company to pass US FDA finished-dosage certification, first to obtain a US ANDA number, first to achieve large-scale sales of finished dosages in the US market, and first to successfully challenge an original US patent. It was listed on the Shanghai Stock Exchange in 2003 and was founded by Chen Baohua and Zhou Minghua.

Zhejiang Huahai Pharmaceutical Co., Ltd. was founded in 1989 and is headquartered in Zhejiang, China. It was founded by Chen Baohua and Zhou Minghua. In 2003, it was listed on the Shanghai Stock Exchange. Over more than 30 years of development, the company states it has pursued coordinated development of traditional and new quality productive forces, actively building four ecosystems: active pharmaceutical ingredients, generic drugs, innovative drugs and internationalization. It states it has achieved four "firsts" in China's pharmaceutical internationalization: first Chinese pharmaceutical company to pass US FDA finished-dosage certification, first to obtain a US ANDA number, first to achieve large-scale sales of finished dosages in the US market, and first to successfully challenge an original US patent. It also states its total export volume of Western finished drugs has ranked first among Chinese pharmaceutical companies for many consecutive years, and that in 2018 Huahai (USA) was named among the top ten fastest-growing generic drug companies in the United States, ranking first among US generic drug companies in prescription volume growth. It states that more than 30 of its products rank in the top three in US market share, with more than 10 products ranking first.

• 2025

  Finished drug smart factory selected for 2025 Zhejiang Province First Batch of Advanced Smart Factory List.

• 2025

  Awarded 'National Civilized Unit' title.

• 2018

  Huahai (USA) named among top ten fastest-growing generic drug companies in the US by prescription volume.

• 2003

  Listed on the Shanghai Stock Exchange.

• 1989

  Company founded in Zhejiang, China by Chen Baohua and Zhou Minghua.

• First Chinese pharmaceutical company to obtain US FDA finished dosage approval.

• First Chinese pharmaceutical company to receive a US ANDA number.

• First Chinese pharmaceutical company to achieve large-scale finished dosage sales in the US market.

• First Chinese pharmaceutical company to successfully challenge an original drug patent in the US.

A pharmaceutical enterprise integrating chemical drugs, biologics, pharmaceutical packaging and trade distribution, committed to providing high-quality medical and health products to patients worldwide and improving accessibility.

• Finished pharmaceutical products

  Cardiovascular, central nervous system, antiviral and other categories, including both domestic and overseas finished formulations.

• Active pharmaceutical ingredients & intermediates

  API and intermediate products.

• Import and export trade services

  Import and export trade services.

• Pharmaceutical packaging

  Pharmaceutical packaging.

• Technical services

  Technical services.

• 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 Zhejiang Huahai Pharmaceutical, prompting recalls of affected medicines in multiple countries; the timing of disclosure and recall in China drew scrutiny. The company halted production and described its risk assessment and communications with regulators; subsequent restrictions were placed by European and U.S. authorities on certain products linked to its Chuannan production site. The incident was confined to the affected API and that facility.

  Source

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1. 1首页 - 浙江华海药业股份有限公司huahaipharm.com
2. 2总裁寄语 - 浙江华海药业股份有限公司huahaipharm.com
3. 3企业简介 - 浙江华海药业股份有限公司huahaipharm.com
4. 4制剂产品 - 浙江华海药业股份有限公司huahaipharm.com
5. 5華海藥業 - Wikidatawikidata.org
6. 6華海藥業 - 维基百科zh.wikipedia.org
7. 7NDMA impurity detected in valsartan API, triggering global recalls and import restrictionsthepaper.cn
8. 8NDMA impurity detected in valsartan API, triggering global recalls and import restrictionsthepaper.cn
9. 9NDMA impurity detected in valsartan API, triggering global recalls and import restrictionsyicai.com