Huahai Pharmaceutical

Zhejiang Huahai Pharmaceutical Co., Ltd. was founded in 1989 and is headquartered in Zhejiang Province, China. Its main business covers chemical and biological medicines, pharmaceutical packaging, and trading. The company states it has more than 40 branches and subsidiaries around the world, including in the United States, Japan, Germany, Russia, Spain, and India, and that it provides medical and health products to approximately 200 countries and regions. Its products cover therapeutic areas including cardiovascular, central nervous system, and anti-viral. It describes itself as one of the global leading manufacturers for cardiovascular and central nervous system products, and as the first Chinese pharmaceutical company to pass US FDA certification for finished pharmaceutical products, obtain ANDA approval for a self-developed product, and achieve large-scale sales of finished dosages in the United States.

Huahai Pharmaceutical was founded in 1989 and is headquartered in Zhejiang Province of China. It states it has more than 40 branches and subsidiaries around the world, including in the United States, Japan, Germany, Russia, Spain, and India. The company describes itself as the first Chinese pharmaceutical company that passed the US FDA certification for finished pharmaceutical products, obtained ANDA approval for a product developed by itself, and materialized large-scale sales of finished dosages in the United States.

• 2020

  Huahai held its first 'Science and Technology Festival'.

• 2020

  Hua Hai College was established.

• 2020

  Zhejiang Vocational Drug Inspection Training Base officially settled in Huahai.

• 2020

  Huahai donated 1 million yuan to support poverty alleviation work in China.

• 2020

  Huahai was listed as one of the top 100 pharmaceutical companies in China.

• 2020

  Huahai Network College officially launched.

• 1989

  Huahai Pharmaceutical was founded and headquartered in Zhejiang Province, China.

One of the global leading manufacturers for cardiovascular and central nerve system products; pioneer in the internationalization of China's pharmaceutical industry.

• Finished Pharmaceutical Products

  Finished dosage forms developed and manufactured by Huahai, including products approved for sale in the United States.

• APIs & Intermediates

  Active pharmaceutical ingredients and intermediates, with a focus on cardiovascular and central nervous system therapeutic areas.

• Pharmaceutical Packaging Components

  Packaging components for pharmaceutical products.

• Import and Export Trade Services

  International trade services for pharmaceutical products through Zhejiang Huahai Import & Export.

• CMO & Other Services

  Contract manufacturing organization services including process development, formula development, clinical trial medicines, API production, intermediates, formulated products (including lyophilization), and packaging.

• 2018

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

  In 2018, the valsartan active pharmaceutical ingredient (API) produced by Huahai Pharmaceutical was found to contain the NDMA impurity. Multiple countries initiated recalls of affected medicines, and questions were raised about the timing of domestic disclosure and recalls. The company halted production and explained 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 API and site involved.

  Source

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1. 1Home - Zhejiang Huahai Pharmaceutical Co.,Ltd.en.huahaipharm.com
2. 2Company Profile - Zhejiang Huahai Pharmaceutical Co.,Ltd.en.huahaipharm.com
3. 3Company Culture - Zhejiang Huahai Pharmaceutical Co.,Ltd.en.huahaipharm.com
4. 4CMO Services - Zhejiang Huahai Pharmaceutical Co.,Ltd.en.huahaipharm.com
5. 5Huahai Pharmaceutical (China) - Wikidatawikidata.org
6. 6NDMA impurity found in valsartan API, triggering global recalls and import restrictionsthepaper.cn
7. 7NDMA impurity found in valsartan API, triggering global recalls and import restrictionsthepaper.cn
8. 8NDMA impurity found in valsartan API, triggering global recalls and import restrictionsyicai.com