Drug Product manufacturing

Amid the new wave of pharmaceutical innovation, small molecule drugs are regaining momentum. As more highly potent, poorly soluble, and precisely targeted compounds enter development pipelines, drug product development is evolving from a manufacturing step into a strategic bridge connecting science and clinical performance, pursuing greater precision, intelligence, and regulatory excellence to maximize the value of each molecule.

Leveraging its deep expertise and forward-looking strategy in small molecule development, ChemExpress offers a one-stop small molecule drug product manufacturing platform. Guided by science, driven by efficiency, and committed to quality, we empower global partners to accelerate the clinical and commercial realization of innovative small-molecule therapies.

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One-Stop Small Molecule
CDMO Platform

From R&D to commercialization, we integrate CRO & CDMO capabilities across small molecules—delivering end-to-end services in RSM, intermediate, API, HPAPI and drug products.

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Green Chemistry &
Enabling Technology

We specialize in complex chemistry—chiral molecules, HPAPI, heterocycles, ADC linkers, and etc.—with enabling technologies including flow chemistry, High Throughput Experimentation, biocatalysis, and Solubility-Enhancing Technologies.

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Global Compliance &
Cost Efficiency

With Multiple GMP-compliant sites, we ensure regulatory excellence. Our tailored CDMO strategies help reduce costs, minimize tech transfer, and accelerate the path to market.

Our Services

Our expert team combines advanced technology platforms with extensive project experience to deliver end-to-end drug product manufacturing services spanning pre-formulation, formulation process development, clinical supply, process validation, and commercialization. ChemExpress is dedicated to being your most reliable and value-driven CDMO partner.

Our Service Scope Includes

Drug Product Manufacturing Solutions

  • Pilot-scale Production and Registration Batch Manufacturing
  • Production of Clinical Trial Samples
  • Development and Production of Placebos
  • Hormone Topical Preparations
  • Contract Commercial Manufacturing for Marketing Authorization Holder (MAH)
  • Repackaging, Blinding, and Labeling of Clinical Samples
  • Transfer and Validation of Analytical Methods
  • Stability Studies

Drug Product cGMP Capacity

  • Formulation Development and Manufacturing: tablets, hard capsules, granules, powders, creams, ointment and gels, including anti-tumor drugs and topical hormone preparations
  • Oral Solid Dosages: 4 commercial-scale workshops, ~1 billion units per year
  • Semi-solid Topical Dosages: 3 commercial-scale workshops, total capacity~50 million tubes per year
  • Solid Dispersion: 1 large scale topical preparation line
  • Batch Size Supported: ~3,000 to ~3,000,000 units (tablets/capsules)

Why Partner with ChemExpress

Extensive Experience
With over 20 years of dedicated CMC experience, we have served over 200 NME projects worldwide, ranging from preclinical, clinical to commercialization. 8 drugs of MAH clients have been approved for marketing and entrusted for commercial production.
Advanced Technology Platforms
We leverage enabling technologies including spray dried dispersion, hot melt extrusion, and etc. to deliver innovative formulation solutions that overcome solubility challenges of small-molecule compounds.
Regulatory Compliance
We have successfully passed 6 China NMPA inspections, completed over 100 customer GMP audits worldwide, including clients from China, the U.S., and the EU, and passed 3 EU third-party QP on-site GMP audits.
Specialized cGMP Facilities
8 independent Class D manufacturing areas in operation, with oral solid dosages and semi-solid topical dosages, providing high-standard cGMP manufacturing support for a wide range of dosage forms.
Pediatric Formulation Expertise
We possess proven experience in pediatric formulations, offering extensive capabilities in developing and manufacturing a variety of child-friendly dosage forms.

Our Sites

R&D Site

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Shanghai 2Y-Chem R&D Center
Small Molecule Drugs CMC Development

Manufacturing Site

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2Y-Biopharma Jiangsu Qidong GMP Manufacturing Site
Drug Product Process Development and Manufacturing

Related Services

Drug Discovery Services

We specialize in complex synthesis routes and accelerate drug discovery through flexible collaboration models and cost-effective R&D strategies.

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Process Development

We provide scalable and cost-effective processes, ensuring a smooth transition to GMP production and supporting technology transfer.

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Drug Substance Manufacturing

We provide integrated Drug Substance services—from early-stage process optimization to GMP production and regulatory support.

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Regulatory CMC Support

Well experienced with the regulatory management and requirements for pharmaceutical products in the USA, China, Japan and EU. We successfully assisted clients in a total of 140+ US-China dual IND filing cases.

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Analytical Development & Quality Control

We provide comprehensive method development, validation, stability studies, ICH-compliant testing, and have fully equipped analytical instruments and GMP labs to ensure the quality of drug substances and drug products.

FAQs

The batch size ranges from about 3,000 tablets/capsules to 3,000,000 tablets/capsules, depending on the specific product and manufacturing process.

We support dosage forms such as oral solid tablets, capsules, granules, powders, and topical semi-solid creams, ointments, and gels.

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