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Zhejiang Poly Pharmaceuticals Co., Ltd. (hereinafter referred to as "Zhejiang Poly"), a wholly-owned subsidiary of Hainan Poly Pharmaceutical Co., Ltd., underwent an on-site inspection for current Good Manufacturing Practices (cGMP) by the U.S. Food and Drug Administration (FDA) from July 17, 2023, to July 25, 2023.
The company recently received the Establishment Inspection Report (EIR) issued by the U.S. FDA, indicating that the company's pharmaceutical manufacturing activities continue to meet the requirements of cGMP set by the U.S. FDA. This provides a solid guarantee for the company's ongoing expansion into the U.S. market and has a positive impact on expanding its presence in regulated global markets.
Product Information
Amiodarone Hydrochloride Injection
Mainly used to treat severe arrhythmias when oral administration is not appropriate, especially in the following cases:
1. Atrial arrhythmias with rapid ventricular response.
2. Ventricular tachycardia associated with the Wolff-Parkinson-White syndrome.
3. Severe ventricular arrhythmias.
4. Cardiopulmonary resuscitation in cases of ventricular fibrillation that do not respond to external defibrillation.
Oseltamivir Capsules
Mainly used for the treatment of:
1.Adults and children aged 2 weeks and older with acute, uncomplicated influenza caused by influenza A or B virus and who have been symptomatic for no more than 48 hours.
2.Adults and children aged 1 year and older for the prophylaxis of influenza.
U.S. Market Situation
In the U.S. market, the annual sales volume of Amiodarone Hydrochloride Injection is approximately 4.1 million vials, with sales revenue reaching $21 million (equivalent to approximately 150 million RMB). Before the outbreak of the pandemic, Oseltamivir Capsules had an annual sales volume of up to 750 million capsules, with sales revenue reaching $200 million (equivalent to approximately 1.468 billion RMB). While sales volumes have been affected by the pandemic, the market is expected to gradually recover rapidly as the pandemic recedes.
Workshop and Production Line Overview
Zhejiang Poly possesses five formulation workshops, including solid dosage, ointments, injections, eye drops, and prefilled syringes, with multiple production lines for tablets, capsules, granules, oral liquids, ointments/creams, small-volume injections, eye drops, and prefilled syringes, among others, offering a wide range of dosage forms.
The two varieties that have passed the FDA audit are produced on the solid dosage production line and the small-volume injection production line in the injection workshop.
In the solid dosage workshop, the design and construction conform to FDA, EU, and the latest GMP standards. It is equipped with pharmaceutical equipment from top imported brands such as Bosch, Famar, and Italy's ROMACO. The workshop handles various complex formulations, including wet granulation, melt granulation, high-shear granulation, dry granulation, extrusion spheronization, and high-viscosity shearing, as well as products with special environmental requirements (e.g., humidity below 25%). The annual production capacity can reach 3 billion tablets/capsules.
In the injection workshop, it has been built in accordance with FDA, EU, and the latest GMP standards and uses top-quality pharmaceutical equipment. Three independent compounding systems and one special material compounding system can accommodate different scales of compounding, ranging from 35kg to 1100kg, and are suitable for compounding sensitive metal materials. Advanced technology for nitrogen protection is employed before, during, and after the compounding process, ensuring stable and effective control of oxygen residuals to below 2%. Currently, there are molds available to meet production needs for 2ml, 5ml, 10ml, 20ml vial injections or lyophilized powder injections, with an annual production capacity of approximately 100 million vial injections and 20 million lyophilized powder injections.
Collaboration Opportunities
As of this FDA approval, Zhejiang Poly has already received international certifications for several production lines, including tablets, capsules, granules, and small-volume injections, complying with the standards of the United States, the European Union, and other countries. In 2024, international production capacity will be developed for oral liquids, ointments/creams, eye drops, prefilled syringes, and more. Throughout this process, Zhejiang Poly has established a comprehensive international manufacturing and quality control system and boasts an excellent team for efficient research and international registration. Poly Pharmaceuticals has also developed a mature international market expansion system.
Zhejiang Poly is willing to provide comprehensive customized services to CDMO/CMO partners aspiring to enter the international market and is open to deep collaboration with international companies for mutual success.
Hainan Poly Pharmaceutical Co., Ltd. was founded in 1992 in Haikou and is a leading Chinese pharmaceutical company with a focus on internationalization. It is also recognized as a demonstration enterprise for intelligent manufacturing by the Ministry of Industry and Information Technology of China. After listing on the Growth Enterprise Market in 2017, the company rapidly became one of China's top 100 technological innovation companies within three years. Since its involvement in internationalizing pharmaceutical products, the company has obtained more than 140 international marketing authorizations, and its products are exported worldwide.
Zhejiang Poly Pharmaceuticals is currently involved in the development of eight projects under the national major science and technology special program "R&D of Pediatric Medicines and Key Technologies." The Pediatric Medicine Base has been included in the Ministry of Industry and Information Technology's 2016 industrial transformation and upgrading initiative, "Made in China 2025," as a key project for pediatric medicines. It is also among the first members of the China Pediatric Drug Research and Industrialization Alliance.
