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CHANGZHOU PHARMACEUTICAL FACTORY

/ COMPANY INTRODUCTION /

Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu province, China, Changzhou pharmaceutical Factory has a rich history & Lineage in the pharmaceutical sector. The company was founded in 1949 by (Tan Ruiting) with a registered capital 108 million yuan and the company was restructured as a Changzhou pharmaceutical Factory under the aegis of Shanghai Pharma Group.

The Chinese business of Changzhou pharmaceutical factory was full fledged sales & marketing organization,Changzhou Pharma is a one of the prominent players in the Chinese pharmaceutical formulations market with a strong foothold across multiple therapies. The company have more than 1500 employees across the country and has earned a reputation amongest the Chinese pharmaceutical companies for providing innovative, comprehensive and complete healthcare solutions.

At Changzhou pharmaceutical Factory, we have one of the strongest global commercial infrastructures in the industry, with a balanced reach across US, Europe, the Asia Pacific region and emerging markets. Our high quality manufacturing dedicated facilities for Oncology, Non Oncology, Complex Generics, OTC-Products and sterile injectables, scientific excellence and vast supply chain network to improve access to medicine for patients worldwide.

The company mainly involves leading pharmaceutical manufacturer a wide range of key Intermediates, Active pharmaceutical ingredients, Finished Formulations meet with global standards, Changzhou Pharmaceutical Factory it covers an area of 300,000㎡ including R&D, dedicated manufacturing, international marketing office. And we maintain an industry -leading pipeline, composed of numerous complex generics and state owned brands. The company annually brings 800 tons of API's and 3000 millions of Finished dosage forms across the Globe.

Founded in year 1949

1.7

billion
Total Assets

300,000

m²
Total area

1500

Number of employees

1

Wholly-owned
Subsidiary

2

Drug
Research Institutes

80

Dosages Approval

50+

Kinds
APIs, Intermediates

8

Billion Annual Average
Production Capacity Of Dosages

1000+

Ton
API Capacity

QUALITY NAGEMENT SYSTEM

We follow one quality standard system Globally at Changzhou Pharma. We believe that the key to strengthening the foundation of a responsible brand lies in consistently achieving high standards of quality in everything we do. We ensure its implementation across different cross functions,Research and Development, Manufacturing operations. Our focus over the past few years has been to enhance our Quality Management Systems to meet and exceed the current expectations of regulatory authorities such as CFDA, US FDA, EU GMP, TGA, MCC, PMDA, KFDA, etc.
We’re committed to achieving best quality, safety, efficacy to controls to ensure that every product released from our manufacturing facility adheres to all applicable quality and regulatory standards.The Quality by Design (QbD) team and Development Quality Assurance (DQA) team work closely with the R&D function to monitor quality during clinical trials, tech transfer and developing molecules.
Our strong commitment to key success, Since 1984 we have been strong track record,successfully cleared 19 times US FDA audits including (16 Times API's+ 3 Times FDF),and alsosuccessfully cleared 5 times EU GMP audits including (3 Times APIs + 2 Times FDF), and alsoapproved PMDA also 3 times +1 time KFDA audits for APIs.

1984

Hydrochlorothiazide/
Doxycycline

2016

Rosuvastatin Tablets

2017

Doxycycline Capsule

2020

Levethracetam Extended-release Tablets

Advanced Analytical laboratory instruments, with dedicated lab suits, 21CFR complies regulatory systems,Quality by Design Principles (QbD) for Sustainable Quality of product life cycle.

We are investing in electronic applications, enabling the organization to establish harmonized processes through automation, and to meet the advanced technologies to put analysis and risk indication abilities to a new level of execution and control.

We have strong regulatory team to support to national and internationalization of DMF’s and CTD of filings.

MANUFACTURING CAPABILITIES
WORLD CLASS ADVANCED EQUIPMENTS

We have state-of-the-art manufacturing facilities that are cGMP compliant in conformity with national and international standards. Additionally, we have dedicated across all Changzhou Pharma Quality Control Laboratories which significantly improve compliance in our laboratories’ data management and Dedicated walking Stability Chambers for Different climatic zones and in line with ICH. Our facilities ensure quality through constant upgradation of equipment, adoption of technological advances and implementation of industry bench marked practices. We have developed a robust system to manufacture products that adhere to stringent specifications & in-process controls subsequently leading to high product quality.
Pharmacovigilance:
We have a strong Pharmacovigilance team is an essential of quality of its products. Our robust pharmacovigilance system is equipped to handle and process safety related complaints from multiple stakeholders such as drug stores, patients and healthcare representatives among others. Complaints related to drug safety are directed to the pharmacovigilance team. we have developed a national pharmacovigilance system for effective handling and processing of drug safety related complaints. The pharmacovigilance team also undertakes measures to review current literature to understand the evolving drug reactions. As a part of this follow-up, we enquire about the patient’s safety and obtain adequate information to assess the safety profile of a drug.
We strive to update our pharmacovigilance practices by improving resource allocation, establishing effective partnerships with vendors and implementing governance mechanisms to adapt ourselves to the changing regulatory landscape.

Korea Countec Bottled Packaging Line

Taiwan CVC Bottled Packaging Line

Italy CAM Board Packaging Line

German Fette Compacting Machine

Special die design ensured pressure holding time doubled, higher accuracy, better chip hardness and brittle degree.

Japan Viswill Tablet Detector

The appearance quality of the product is checked grain by grain with a speed of 100,000 pieces/hour, and the elimination accuracy is 99.99%.

DCS Control Room

Improved the automation level of API workshop production, reduced labor handling and cost, and improved stability of the quality.

OUR EXPERIENCE

Our most valuable asset is our people. We have strong team of highly driven individuals who are dedicated, talented and work with a passion to achieve goals, Quality is our individual responsibility.
Our highly qualified leadership team drive the company on great values, and also several mid level team involves, Synthesis of API’s, Finished Product, Quality management, Regulatory, Marketing, Information Technology
We have successfully overcome challenges such as growing in line with regulatory procedures, demanding compliance requirements and stringent quality standards as a result of our robust Quality Control systems. The Company functions on a business model with a futuristic outlook that envisions the anticipated regulatory developments. This prepares us to adapt readily to the changing environment and ensure business continuity.
With significant presence in more than 50 countries, Changzhou Pharma is all poised to spread wings across globe with strong technical capabilities and international accreditations. To enable strategic differentiation, Changzhou Pharma’s international business is segregated into US, Europe, Brazil and Rest of the World.
Changzhou Pharma have been working with Global top customers like, Novartis, Sanofi, GSK, Merck, Roche, Pfizer, TEVA, Apotex, and Sun Pharma etc.