Three Pharmaceutical Products Secure Overseas Approvals: Shanghai Pharmaceuticals and Poluo Pharma Announce Export Milestones

Nov 16, 2025 18:23 CST Updated 18:23

SPH

Pharmaceutical R&D and Manufacturing

AstraZeneca

Biopharmaceutical Manufacturer

‍ComeSource: Corporate Announcement Editor: wangxinglai2004

Recently, two pharmaceutical companies respectively released announcements on the progress of three products being exported and listed overseas.Two SPH Preparations Receive FDA Approval NumbersPro Pharma's API Obtains CEP Certificate.

Pro Pharma's API Obtains CEP Certificate

1. Basic Information of the Drug

API Name: Venlafaxine Hydrochloride

Manufacturer/Holder: Zhejiang Puluojia Pharmaceutical Co., Ltd.

Certificate No.: CEP 2023-219- Rev 00

Issuing Authority: European Directorate for the Quality of Medicines (EDQM)

Validity Period: This certificate becomes effective from October 28, 2025.

II. Other Phases of the Drug

Venlafaxine Hydrochloride, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is used to treat various types of depression (including depression with anxiety) and generalized anxiety disorder.

SPH Formulations Receives FDA Approval

1. Basic Information of the Drug

Drug Name: Ticagrelor Tablets

Dosage Form: Tablets Specifications: 60mg, 90mg

Application Item: ANDA

Applicant: CHANGZHOU PHARMACEUTICAL FACTORY

ANDA No.: ANDA216187

II. Other Drug-Related Information

Ticagrelor Tablets are used in patients with acute coronary syndrome, including those treated with medication and percutaneous coronary intervention, to reduce the occurrence rate of thrombotic cardiovascular events.

The original research was developed by AstraZeneca and launched in the United States in 2011. In May 2021, CHANGZHOU PHARMACEUTICAL FACTORY submitted an ANDA application for this drug to the US FDA, and it has recently received final approval for marketing. As of the date of this announcement, the company has invested approximately RMB 9.6713 million in R&D expenses for this drug.

SPH Formulations Receives FDA Approval Number

I. Basic Information of the Drug

Drug Name: Eslicarbazepine Acetate

Dosage Form: Tablets

Specification: 200mg, 400mg, 600mg, 800mg

Application Item: ANDA

Applicant: SPH Zhongxi Pharmaceutical Co., Ltd.

ANDA No.: ANDA211247

II. Other phases of the drug

Eslicarbazepine Acetate Tablets are used to treat partial-onset seizures in patients aged 4 years and older. They were initially developed by Bial-Portela, Eisai, and Dainippon Sumitomo and launched in the United States in 2013.

In January 2018, SPH Zhongxi submitted an ANDA application for this drug to the U.S. FDA. It received tentative approval for four specifications of the drug in June 2020 and has recently obtained final approval for marketing. As of the date of this announcement, the company has invested approximately RMB 15.9371 million in research and development expenses for this drug.

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