Nanjing Hanxin Pharma - CDMO/CMO

Drug Substance (CDMO/CRO)

Drug Substance CDMOs and CROs provide essential services in the development and manufacturing of active pharmaceutical ingredients (APIs). These organizations specialize in early-stage research, process development, and GMP-compliant manufacturing of drug substances for clinical and commercial use.

Pharmaoffer's Drug Substance CDMO/CRO category includes partners with expertise in small molecules, biologics, peptides, and complex chemistry, all operating under strict regulatory compliance. These providers help companies scale from lab to market efficiently and cost-effectively.

Key Functions of Drug Substance CDMOs/CROs:

• API Research and Development: Providing early-stage discovery support, custom synthesis, and process optimization to streamline the development of drug substances.

• Process Scale-Up and Tech Transfer: Transitioning from bench-scale to pilot and commercial scale production with validated methods and reproducibility.

• GMP Manufacturing: Delivering high-quality API batches in GMP-certified environments, adhering to FDA, EMA, and other international standards.

• Analytical Services: Offering comprehensive analytical method development and validation to ensure consistent quality and regulatory compliance.

• Flexible and Specialized Capabilities: From small molecule synthesis to biologic and peptide manufacturing, these partners provide specialized services tailored to product-specific needs.

Explore Leading API CDMOs and CROs

Pharmaoffer connects you with trusted CDMOs and CROs for drug substance development. Our platform enables seamless access to specialized service providers equipped to support your API lifecycle from discovery to commercialization.

Drug Product (CMO)

Drug Product CMOs focus on the manufacturing and packaging of finished pharmaceutical dosage forms. These contract partners provide scalable production solutions that meet global regulatory and quality standards, supporting pharma companies throughout the drug product lifecycle.

Pharmaoffer’s Drug Product CMO category includes providers capable of manufacturing oral solids, injectables, topical formulations, and more—whether for clinical trials or commercial distribution.

Key Functions of Drug Product CMOs:

• Formulation Development: Supporting the transition from drug substance to drug product through formulation optimization and compatibility testing.

• Clinical and Commercial Manufacturing: Offering pilot-scale to high-volume manufacturing for various dosage forms under GMP conditions.

• Packaging and Serialization: Providing primary and secondary packaging with serialization and tamper-proof labeling to meet compliance requirements.

• Regulatory Support: Ensuring that all production meets FDA, EMA, and ICH standards for drug product quality, safety, and traceability.

• Flexible Production Lines: Handling diverse dosage forms including tablets, softgels, liquids, and sterile injectables.

Partner with Proven Drug Product CMOs

Through Pharmaoffer, discover CMOs that excel in drug product manufacturing. Whether you need small-scale batches or full commercial output, our platform connects you with the right partners for compliant, cost-effective solutions.

Oral solid products

Oral solid products include tablets and capsules. CMOs provide formulation development, manufacturing, and packaging of solid dosage forms.

Sterile injectables

Sterile injectables are critical for acute therapies. CMOs provide aseptic manufacturing, vial and syringe filling, and lyophilization services.

Powders & Granules

Powders and granules are flexible oral formats. CMOs support blending, granulation, and GMP filling for pharmaceutical applications.

Tablets & Capsules

Tablets and capsules are common oral solid forms. CMOs offer formulation, compression, encapsulation, and GMP-compliant manufacturing services.

Liquid Vials

Liquid vials are injectable formats requiring aseptic filling. CMOs offer vial washing, sterilization, filling, and sealing services.

Prefilled Syringes

Prefilled syringes enhance ease of use and reduce contamination risk. CMOs provide sterile filling, plunger insertion, and labeling services.

Lyophilized Powders

Lyophilized powders require freeze-drying expertise. CMOs offer lyophilization, sterile filling, and capping of drug products.

Ampoules

Ampoules are hermetically sealed units for injectables. CMOs offer washing, filling, and sealing of glass ampoules under sterile conditions.

Prefilled Pens

Prefilled pens combine drug delivery with device technology. CMOs handle filling, device assembly, and GMP packaging for patient-ready products.