From June 22, 2023, to June 30, 2023, Poly Pharmaceuticals underwent an on-site inspection by the United States Food and Drug Administration (US FDA) for cGMP (current Good Manufacturing Practice). Recently, the company received the Establishment Inspection Report (EIR) issued by the US FDA, indicating that the company's drug manufacturing activities continue to meet the requirements of cGMP set by the US FDA. It provides a solid guarantee for the company to continue to expand the US market, and has a positive impact on the expansion of the global normative market.
01 Company Name:
Hainan Poly Pharmaceutical Co., Ltd.
02 Inspection Purpose:
PAI (Pre-approval inspection) and routine inspection
03 Inspection Scope:
Amiodarone raw material, Acyclovir raw material, Acyclovir injection, and other products
04 Inspection Workshops:
Raw material workshop and injection workshop
1.Amiodarone Raw Material:
Amiodarone is an anti-arrhythmic drug used clinically to treat severe cardiac arrhythmias, especially in the following cases: atrial arrhythmia with rapid ventricular rhythm; Tachycardia in W-P-W syndrome; Severe ventricular arrhythmia; Cardiopulmonary resuscitation of ventricular fibrillation related cardiac arrest without external electrical defibrillation.
Statistics show that in the United States, Amiodarone drugs are mainly available in tablets and injections. 354.8 tons of amiodarone APIs have been consumed in 2022.
2.Acyclovir Raw Material and Acyclovir Injection:
Acyclovir is an antiviral drug used clinically for the treatment of: primary and recurrent mucosal infections and herpes simplex (HSV-1 and HSV-2) in immunodeficient patients; Initial clinical onset of severe genital herpes in immunodeficient patients; Herpes simplex encephalitis; Neonatal herpes simplex infection; Chickenpox - herpes zoster (shingles) infection in immunodeficient patients.
Statistics show that in the United States, Acyclovir drugs are mainly available in various forms, including tablets, capsules, oral suspensions, injections, and topical creams.
$127 million worth of acyclovir injections have been sold and 1,013 tons of acyclovir APIs have been consumed in 2022.
Acyclovir injection, being highly alkaline, poses a risk of glass delamination when packaged in glass vials, which can lead to glass particles entering the bloodstream. The acyclovir injection of Poly Pharmaceutical uses plastic bottles made of the same material as the original drug, a copolymer of propylene (COPP), which has high mechanical strength and corrosion resistance to avoid being degraded by alkaline materials. Therefore, compared with the domestic glass bottle of acyclovir, Poly Pharmaceutical COPP material bottle can better protect the safety of patients.
Hainan Poly Pharmaceutical Co., Ltd. was founded in 1992 in Haikou, China. It is a leading international pharmaceutical company and a demonstration enterprise for intelligent manufacturing recognized by the Ministry of Industry and Information Technology. It has been included in the key projects for children's medicines under the "Made in China 2025" initiative by the Ministry of Industry and Information Technology. In 2023, Hainan Poly received the "AEO" advanced certification from customs.
Previously, Hainan Poly had successfully passed multiple on-site audits by the US FDA and the European Medicines Agency (EMA). As a leading international pharmaceutical company in China, Poly Pharmaceutical has consistently adhered to high global quality standards and is one of the few platforms in China for the research and production of raw materials and injectables. It is also one of the few suppliers simultaneously approved by regulatory authorities in the United States, China, the European Union, and more for raw materials, drug formulations, and GMP intermediate CDMO.
Currently, with high-standard quality management and state-of-the-art production lines, Poly Pharmaceutical has registered 29 products, including injectable azithromycin, injectable voriconazole, injectable ganciclovir, and dry suspension of azithromycin, in countries such as Europe and the United States. More than 140 international marketing approvals has obtained. Among them, 21 products have received 36 FDA marketing approvals.
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