Executive Summary
Zhejiang Huahai Pharmaceuticals Co., Ltd. is a China-based company, principally engaged in the manufacture and distribution of active pharmaceutical ingredients (APIs), intermediates and preparations. The Company’s main products are classified as -pril series, -sartan series and preparations, including irbesartan tablets, paroxetine hydrochloride tablets, risperidone tablets, fosinopril sodium tablets, as well as irbesartan and hydrochlorothinzide tablets, among others. The Company also provides related technical support services. The Company distributes its products in domestic and overseas markets.
It was founded in 1989, and is headquartered in Zhejiang Province of China. It has a total staff of over 6,500 people and has more than 40 branches and subsidiaries around the world, including the United States, Japan, Germany, Russia, Spain, and India. The company is one of the global leading manufacturers for cardiovascular and central nerve system, products.
In the United States, Huahai US, Inc. develops, acquires, licenses, registers, markets, and distributes prescribed generic pharmaceutical products. It offers cardiovascular, CNS, Alzheimer’s, anti-diabetes, and anti-HIV products to the US market. Huahai US, Inc. is a wholly owned subsidiary of Zhejiang Huahai Pharmaceutical Co. Ltd., the first Chinese manufacturer approved by the US FDA in 2007 for manufacturing finished products. It was founded in 2004 and is located in Cranbury, New Jersey.
History of Zhejiang Huahai Pharmaceuticals
Zhejiang Huahai was established in January 1989 as Linhai Xunquiao Synthetic Chemical Factory. It was renamed Zhejiang Huahai Pharma in April 1997, and set up their first wholly-owned subsidiary in August 1998. In January 2000, the company won the title of Top 500 Private Enterprises in China for the first time.
In the United States, Huahai US was established in 2004, being the first Chinese pharmaceutical company to file an ANDA. In 2010, the company began to market generic finished dosage products through Prinston Pharmaceutical Inc., which was spun off from Zhejiang Huahai Pharmaceutical Co., Ltd. in 2009.
Subsidiaries of Zhejiang Huahai
Zhejiang Huahai Pharmaceuticals has a number of subsidiaries, including but not limted to:
- Huahai US Inc.
- Huahai (Japan) Pharm Co., Ltd.
- Shanghai SynCores Technologies
- Prinbury Biopharm Co., Ltd.
- Shanghai Synergy Pharmaceuticals
- Shanghai Huaao Biopharm Co., Ltd.
- Changxing Pharmaceutical Co., Ltd.
- Jiangsu Galaxy Imp. and Exp., Co., Ltd.
Popular Products of Zhejiang Huahai
Zhejiang Huahai’s most popular products, with their therapeutic areas, are the following:
- Ambrisentan – Anti-hypertensive
- Apixaban – Anti-thrombotic
- Aripiprazole – Anti-psychotic
- Benazepril HCl – ACE Inhibitor
- Canagliflozin – Anti-diabetic
- Candesartan Cilexetil – Angiotensin II Receptor Antagonist
- Captopril – ACE Inhibitor
- Carvedilol – Anti-Hypertensive
- Citalopram Hydrobromide – Anti-depressant
- Clofazimine – Leprosy
- Dabigatran etexilate – Anti-thrombonic
- Dimethyl Fumarate – Multiple sclerosis
- Donepezil HCl – Alzheimer’s disease
- Duloxetine hydrochloride – Anti-depressant
- Enalapril Maleate – ACE Inhibitor
- Eprosartan mesylate – Angiotensin II Receptor Antagonist
- Escitalopram Oxalate – Anti-depressant
- Febuxostat – Chronic Gout drug
- Fosinopril sodium – ACE Inhibitor
- Irbesartan – Angiotensin II Receptor Antagonist
- Ketotifen hydrogen fumarate – Anti-histaminic
- Lamotrigine – Anti-epileptic
- Levetiracetam – Anti-epileptic
- Levodopa – Anti-parkinsonian
- Lisinopril – ACE Inhibitor
- Losartan potassium – Angiotensin II Receptor Antagonist
- Nebivolol – Anti-hypertensive
- Nevirapine – Anti-AIDS
- Olmesartan medoxomil – Angiotensin II Receptor Antagonist
- Paroxetine HCl, anhydrous – Anti-depressant
- Paroxetine HCl, Hemihydrate – Anti-depressant
- Perindopril tert-butylamine – ACE Inhibitor
- Pregabalin – Anti-epileptic
- Quinapril Hydrochloride – ACE Inhibitor
- Ramipril – ACE Inhibitor
- Ranolazine – Anti-angina
- Risperidone – Anti-psychotic
- Rivaroxaban – Rivaroxaban
- Rocuronium Bromide – Muscle Relaxants
- Ropinirole Hydrochloride – Anti-parkinsonian
- Silodosin – Benign Prostatic Hyperplasia
- Sitagliptin – Anti-diabetic
- Tadalafil – Erectile dysfunction
- Telmisartan – Angiotensin II Receptor Antagonist
- Temocapril Hydrochloride – ACE Inhibitor
- Tolvaptan – Congestive heart failure
- Torasemide – Diuretic
- Valsartan – Angiotensin II Receptor Antagonist
- Vildagliptin – Anti-diabetic
- Voriconazole – Anti-fungal
Product Recalls and Lawsuits
- In late 2018, the United States Food and Drug Administration (USFDA) issued a product recall and import ban for Zhejiang Huahai Pharmaceutical’s Valsartan blood pressure medicine. Huahai ran into trouble with the FDA and European regulators after it was discovered that the impurity N-nitrosodimethylamine (NDMA), a suspected cancer causing agent, had been showing up in its API, the result of a manufacturing change the drugmaker made years ago. While the levels of NDMA in Huahai’s valsartan API were trace amounts, they were considered unacceptable, the FDA has said. Further testing has also found N-Nitrosodiethylamine (NDEA), another suspected carcinogen, in the API. There are a number of class action lawsuits with regards to this issue, including Gotenski vs. Huahai and Kruk vs. Huahai, both in New Jersey, and Lewis vs. Huahai in Tennessee.
Litigation Settlements
There are currently no public records of any litigation settlements entered into by Zhejiang Huahai. Settlements of its pending cases remain pending.
Sources:
http://en.huahaipharm.com/ylzjy/index.aspx
https://www.todayonline.com/world/embattled-chinese-drug-maker-get-43-million-government-support
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm480035.htm
https://www.bloomberg.com/profiles/companies/ZHPHAZ:CH-zhejiang-pharmaceutical-co-ltd
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.