Zhejiang Hisoar Pharmaceutical

VIRTUAL BOOTH, Contact Details

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 8 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

37 All APIs, 6 USDMF, 7 CEP/COS, 10 JDMF, 9 KDMF, 7 NDC API, 2 VMF, 29 Listed APIs

INTERMEDIATES

9 ALL Intermediates

9 ALL Intermediates

EXCIPIENTS

1 All Excipients, 1 USDMF

INSPECTIONS & REGISTRATIONS

6 FDA, 6 EDQM, 2 GDUFA

Filters

Digital content

Create Content with PharmaCompass, ask us

INTERVIEW #SpeakPharma

[Sponsored by another company]

Expert Take on CEP 2.0: A New Era of Transparency in Pharmaceutical Regulation

At the recent EDQM conference “Certified for Success: Using the CEP Procedure to Elevate Quality and Drive Trust,” regulatory leaders gathered to discuss one of the most significant shifts in European pharmaceutical oversight recently– the transition to CEP 2.0. In the following article, Karina Boszko, Head of Global Regulatory Affairs and Customer Technical Service at Polpharma API, shares her perspective on the new framework and its impact on transforming regulatory strategies for manufacturers worldwide. A strategic shift beyond just compliance. CEP 2.0 is more than a routine update. It represents a fundamental change in how pharmaceutical companies approach transparency, lifecycle management, and international expansion. Rather than focusing solely on documentation, the framework encourages organizations to treat regulatory excellence as a strategic differentiator, shifting the mindset from static compliance to continuous lifecycle oversight. Regulatory alignment thus becomes a living process that evolves with the product, data, and technology. Embedding this approach across teams will foster a culture of iterative improvement, innovation, and stronger organizational resilience. For many manufacturers, however, this will require introducing significant internal changes, from documentation practices to cross-functional collaboration. CEP 2.0 means faster timelines and higher predictability. But only if your team is ready. One of the most anticipated benefits of CEP 2.0 is more predictable review timelines and consistent submissions. However, leveraging these advantages depends heavily on industry readiness. Regulatory teams must adapt to more streamlined, data-driven processes and ensure that digital tools, training, and workflows support accelerated operations. Organizations that modernize will see multiple operational benefits early, including faster project completion, reduced rework, and quicker access to key markets as standardized documentation and cohesive global expectations will make previously complex or "slow” markets more accessible. For companies pursuing international expansion, CEP 2.0 provides a clearer path to global approvals, cross-market consistency, and enhanced competitiveness. Balancing challenges with opportunity. Despite its promise, the transition to CEP 2.0 is not without challenges. Data privacy, operational costs, supply chain complexity, and pressure on low-margin APIs remain key industry concerns that require striking a balance between stringent compliance and long-term sustainability. Still, companies that efficiently integrate regulatory requirements into scalable operations will not only demonstrate the maturity of their quality systems but also build trust externally, strengthening their reputation and differentiating their business in an increasingly competitive market. Looking ahead to a more collaborative future. CEP 2.0 positions the pharmaceutical sector for a future where regulatory excellence drives global competitiveness. Transparency, harmonization, and a lifecycle approach will increasingly define market leaders. The framework’s success, however, requires ongoing dialogue with regulators. Clear, practical guidance from the EDQM, combined with active feedback from manufacturers, is essential. The more open the collaboration, the more effectively CEP 2.0 will support innovation, quality, and patient safety. The question for every organization is how to approach this moment: as a compliance burden, or as a strategic opportunity to elevate quality, accelerate growth, and build long-term trust. Connect with Polpharma API: Your Partner in Pharma AdvancementFor more information on how Polpharma API can be your strategic ally in drug substance development and manufacturing, contact us at api@polpharma.comLet's embark on a journey of innovation and excellence together.

Impressions: 135

VLOG #PharmaReel

[Sponsored by another company]

Smart & Innovative Custom Manufacturing

This PharmaReel highlights PMC Isochem, a smart custom manufacturing partner that offers Generic APIs, cGMP Intermediates, Vitamin E TPGS, and cutting-edge drug delivery materials, supported by trusted CDMO & CRO services and certified by the USFDA and EDQM.

Impressions: 82

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

This week, PharmaCompass brings you key highlights of the US Food and Drug Administration’s December 2025 list of Off-Patent, Off-Exclusivity Drugs (OPOE) without an approved generic. The OPOE list gets updated every six months.This list highlights drug products that have lost patent protection and regulatory exclusivity, but remain without approved generic competition in the US market. With this list, the FDA hopes to bolster competitiveness in the generics market, improve transparency and encourage the development and submission of abbreviated new drug applications (ANDAs) in markets with little competition.Since December 2021, FDA has been publishing two versions of the OPOE list — one for prescription (Rx) drug products and the other for over-the-counter (OTC) drug products that are approved and marketed under a new drug approval (NDA). Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel)Injectables continue to dominate FDA’s OPOE Rx list; 73 OTC drugs figure in Dec listFDA’s December 2025 OPOE Rx list includes 784 drug products that currently have no approved generics. Out of these, 296 are injectables and 126 are oral solid dosage forms (such as tablets, capsules and modified release forms). In June 2025, the OPOE Rx list had 765 drug products without an approved generic, out of which 304 were injectables, while 109 were oral solid drug forms. The increase in drug products from 765 to 784 from June 2025 to December 2025 was due to the inclusion of additional dosage strengths in the OPOE Rx list. Otherwise, no new drugs were added to the December 2025 OPOE Rx list.The December 2025 OPOE list has 73 OTC drugs, slightly higher than the 69 drugs in the June 2025 list. Among the 73, 21 are oral solid dosage forms.Among the OTC drugs on the December 2025 OPOE list are ibuprofen and ibuprofen sodium (for pain and inflammation), pseudoephedrine hydrochloride and phenylephrine hydrochloride (nasal decongestants), nizatidine and famotidine (for gastroesophageal reflux disease), loratadine, cetirizine hydrochloride and chlorpheniramine maleate (for allergy relief), loperamide hydrochloride (anti-diarrheal), and orlistat (for weight management). Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel)FDA fast-tracks initiatives to accelerate market entry of generics, biosimilarsFDA has launched several regulatory initiatives designed to accelerate the market entry of generics and biosimilars. In October 2025, the agency announced a new pilot prioritization program for the review of ANDAs that aims to encourage and reward investment in drug manufacturing, research and development and strengthen the pharmaceutical supply chain in the United States.Separately, FDA has also come out with a new draft guidance that seeks to simplify biosimilarity studies and reduce unnecessary clinical testing. Through a separate initiative, the agency also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, thereby helping patients and pharmacists choose lower-cost options. Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel) Our viewThe global generic drugs market was valued at US$ 445.62 billion in 2024 and is projected to reach US$ 728.64 billion by 2034, growing at a compound annual growth rate of 5.04 percent from 2025 to 2034. With several diabetes, immunology, oncology and cardiology drugs slated to face patent expirations this year, and continued pressure on drugmakers to improve affordability, we believe the generic market could grow at an even faster rate in the near term.

Impressions: 1598

NEWS #PharmaBuzz

[Sponsored by another company]

Chen Zhicheng, member of the party group and deputy director of the Zhejiang

05 May 2023

// PRESS RELEASE

A new batch of "little giant" enterprises in Jiaojiang District was released

30 Mar 2023

// PRESS RELEASE

Yan Qijun, deputy mayor of Linhai City, and his party visited Haixiang

23 Mar 2023

// PRESS RELEASE

Zhejiang Science and Technology Award Publicity Information Form

20 Feb 2022

// PRESS RELEASE

Zhou Hui, President of China Chamber of Commerce for Import and Export

24 Jun 2021

// PRESS RELEASE

Zhejiang Hisoar Pharmaceutical issues 500 mln yuan financing bills

22 Nov 2016

// REUTERS

Contact Zhejiang Hisoar Pharmaceutical and get a quotation

Zhejiang Hisoar Pharmaceutical is a supplier offers 33 products (APIs, Excipients or Intermediates).

Find a price of Clindamycin Hydrochloride bulk with DMF, CEP, JDMF offered by Zhejiang Hisoar Pharmaceutical

Find a price of Clindamycin Phosphate bulk with DMF, CEP, JDMF offered by Zhejiang Hisoar Pharmaceutical

Find a price of Amorolfine Hydrochloride bulk with CEP, JDMF offered by Zhejiang Hisoar Pharmaceutical

Find a price of Metoprolol Succinate bulk with DMF, CEP offered by Zhejiang Hisoar Pharmaceutical

Find a price of Quetiapine Hemifumarate bulk with CEP, JDMF offered by Zhejiang Hisoar Pharmaceutical

Find a price of Repaglinide bulk with CEP, JDMF offered by Zhejiang Hisoar Pharmaceutical

Find a price of Avibactam Sodium bulk with DMF offered by Zhejiang Hisoar Pharmaceutical

Find a price of Clindamycin Palmitate bulk with DMF offered by Zhejiang Hisoar Pharmaceutical

Find a price of Clindamycin Phosphate bulk with JDMF offered by Zhejiang Hisoar Pharmaceutical

Find a price of Diquafosol Sodium bulk with JDMF offered by Zhejiang Hisoar Pharmaceutical

Find a price of Flunixin Meglumine bulk with CEP offered by Zhejiang Hisoar Pharmaceutical

Find a price of Meropenem bulk with JDMF offered by Zhejiang Hisoar Pharmaceutical

Find a price of Voglibose bulk with JDMF offered by Zhejiang Hisoar Pharmaceutical

Find a price of Atorvastatin bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Biapenem bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Bifendate bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Caspofungin bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Crisaborole bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Ertapenem bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Faropenem bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Florfenicol bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Gamithromycin bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Lifitegrast bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Moxidectin bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Phenylephrine Hydrochloride bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Rivaroxaban bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Rosuvastatin Calcium bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Sacubitril-Valsartan bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Sofalcone bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Tacrolimus bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Thiamphenicol bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Vortioxetine Hydrobromide bulk offered by Zhejiang Hisoar Pharmaceutical

Find a price of Boglibos bulk offered by Zhejiang Hisoar Pharmaceutical

Privacy policy
Terms and conditions
Disclaimers
Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.