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Trusted Pharmaceutical Manufacturing Since 1949

CZ Pharma (Changzhou Pharmaceutical Factory) is a globally recognized manufacturer of high-quality Active Pharmaceutical Ingredients (APIs), intermediates, and finished dosage forms. With over 800 tons of API and 3 billion tablets produced annually, we serve markets across the USA, EU, Japan, and beyond.

CZ Pharma Manufacturing Facility

About CZ Pharma

Established in 1949 in Changzhou, Jiangsu Province, CZ Pharma (Changzhou Pharmaceutical Factory) has grown into a leading global pharmaceutical manufacturer specializing in cardiovascular medicines, APIs, and finished formulations.

With an annual output of over 800 tons of APIs and more than 3 billion tablets, we are committed to delivering high-quality, safe, and effective pharmaceutical products to partners worldwide. Our facilities are approved by the U.S. FDA, EU GMP, PMDA (Japan), and Chinese NMPA.

800+ Tons
APIs Produced Annually
3B+
Tablets Manufactured
9
FDA Audits Passed
3
EU GMP Inspections Passed
CZ Pharma Laboratory

Our Milestones

Company Founded

CZ Pharma is established in Changzhou City in 1949, laying the foundation for decades of pharmaceutical innovation.

1949
1984

FDA Approval

Our API Hydrochlorothiazide receives U.S. FDA approval, marking our entry into the American market.

CEP Certificate

Received CEP certificate for Hydrochlorothiazide, affirming compliance with European standards.

2006
2013

Global Compliance

Passed U.S. FDA audits for the 9th time and EU GMP inspection 3 times, demonstrating consistent quality.

PMDA Approval

Changzhou Pharma and Nantong Chanyoo receive approval from Japan's PMDA, expanding our Asian presence.

2017
2019

Routine FDA Inspection

Changzhou Pharma and Nantong Chanyoo successfully pass FDA routine inspection, maintaining compliance.

Our Products

High-quality APIs, intermediates, and finished dosage forms developed under strict GMP standards. All products are supported by DMF filings and regulatory compliance.

Abemaciclib

Form III | Pilot Batch: 5-8kg

  • High purity and stability
  • Oncology therapeutic area
  • Scalable manufacturing process

Abrocitinib

Form I | Batch Size: ~115kg

USDMF39291

  • JAK1 inhibitor
  • Dermatology applications
  • Fully documented DMF

Agomelatine

Form II | Batch Size: ~9.5kg

USDMF38958

  • Melatonin receptor agonist
  • Antidepressant properties
  • Stable crystalline form

Apixaban

Form N-1 | Batch Size: 1.5-4.2kg

USDMF37883

  • Factor Xa inhibitor
  • Cardiovascular protection
  • High bioavailability

Apremilast

Form B | Batch Size: ~14kg

USDMF37882

  • PDE4 inhibitor
  • Psoriasis and arthritis treatment
  • Well-characterized polymorph

Baloxavir Marboxil

Form I | Batch Size: 10.5-12.7kg

USDMF36657 | EUDMF

  • Influenza antiviral
  • Single-dose treatment
  • Global regulatory support

Canagliflozin Hemihydrate

Hemihydrate | Batch Size: 79.2-89.5kg

USDMF36739 | EUDMF

  • SGLT2 inhibitor
  • Type 2 diabetes management
  • Stable hydrate form

Dabigatran Etexilate Mesylate

Form I | Batch Size: 89.5-99.7kg

USDMF | EUDMF

  • Direct thrombin inhibitor
  • Anticoagulant therapy
  • High-volume production

Captopril

Batch Size: 400kg

USDMF33888 | EUDMF

  • ACE inhibitor
  • Hypertension and heart failure
  • Large-scale manufacturing

Doxycycline Hyclate

Batch Size: 800kg

USDMF13771

  • Broad-spectrum antibiotic
  • High purity and stability
  • One of our largest volume APIs

Our Services

Comprehensive pharmaceutical development and manufacturing services tailored to global regulatory standards.

API Development & Manufacturing

End-to-end API synthesis from lab scale to commercial production, including process optimization, impurity profiling, and regulatory filing support (USDMF, EUDMF).

Finished Dosage Forms

Manufacturing of tablets and other solid dosage forms under strict GMP conditions. Capabilities include formulation development, stability testing, and packaging.

R&D and Analytical Services

Advanced research in polymorph screening, salt selection, and formulation optimization. Full analytical support including method development and validation.

Research & Development

Our R&D center is equipped with state-of-the-art laboratories and staffed by experienced scientists dedicated to innovation in pharmaceutical development.

We focus on process optimization, impurity control, polymorph screening, and formulation development to ensure robust, scalable, and patent-free manufacturing processes.

Polymorph and salt form screening
Process development and scale-up
Impurity profiling and control strategy
Regulatory documentation (CTD, DMF)
Stability studies and shelf-life prediction
R&D Laboratory

Latest News

Stay updated with the latest developments from CZ Pharma.

Company News

CZ Pharma Passes FDA Routine Inspection in 2019

Changzhou Pharma and Nantong Chanyoo successfully passed the U.S. FDA routine inspection, reaffirming our commitment to quality and compliance.

Read More →
Industry News

Global Demand for High-Purity APIs on the Rise

The pharmaceutical industry continues to see increased demand for high-purity, well-characterized APIs, especially in oncology and chronic disease treatments.

Read More →

Contact CZ Pharma

We strive to provide customers with quality products and responsive service. For inquiries about APIs, finished formulations, or partnership opportunities, please reach out.

Address

No. 518 Laodong East Road,
Changzhou, Jiangsu, China 213018

Phone

+86 519 88821493

+86 519 88809235

+86 519 68010600

Hours

Monday–Friday: 9am to 6pm

Saturday–Sunday: Closed

Get in Touch

For product inquiries, samples, quotes, or regulatory information, please contact us through the official website.

Visit Official Website to Contact

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