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Chenghui Shuangda Pharm - CDMO/CMO

Established in 2014, Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is a leading Chinese manufacturer of active pharmaceutical ingredients (APIs) and advanced intermediates. The company operates 6 cGMP-compliant workshops and 9 automated production lines, delivering a monthly production capacity of 100 metric tons. To date, it has filed 22 products with the Center for Drug Evaluation (CDE) in China, registered 4 APIs in the United States Drug Master File (US-DMF), and submitted 7 applications for Certificates of Suitability (CEP) with the European Directorate for the Quality of Medicines (EDQM)‌.Supported by over 100 patents encompassing advanced synthesis and crystallization technologies‌, the company specializes in API manufacturing and offers integrated CDMO (Contract Development and Manufacturing...

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Address: Economic Development Zone ,Pingyuan County, Dezhou City, 253100, Shandong Province
China
China Local time:

23 years of production experience

6 workshops and 9 production lines which has 100t/month production capacity

4 USDMFS & 5 CEPS & 200+ Patents

Our services:

Drug Substance
Drug Product

Production scale:

small
medium
large

Response time:

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Employees:
1000+
Established in:
2014

Upcoming events

Join Us at API China 2025

Join Us at API China 2025

In-person event

We’re excited to invite you to visit our booth ‌10.3E10‌ at ‌API China 2025‌ in ‌Guangzhou‌!📅 ‌Date:‌ May 21-23, 2025📍 ‌Location:‌ China Import

21-05-2025

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Drug Substance (CDMO/CRO)

Fine Chemicals
Fine chemicals are pure, complex chemicals produced in limited quantities for use in pharma and biotech. CDMOs offer synthesis, scale-up, and high-purity manufacturing to support drug substance production.
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Intermediates
Pharmaceutical intermediates are compounds used in the production of APIs. CDMOs play a crucial role in synthesizing, scaling, and ensuring the quality of these intermediate compounds to support efficient drug manufacturing.
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Small Molecule APIs
Small molecule APIs form the backbone of many pharmaceutical drugs due to their low molecular weight and ease of synthesis. They are widely used in treating a range of diseases and are typically produced through chemical synthesis in GMP-compliant facilities.
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Drug Product (CMO)

Ophthalmic Products
Ophthalmic products are sterile formulations for eye treatment. Specialized CMOs offer aseptic manufacturing, filling, and packaging of eye drops, ointments, and gels.
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Oral solid products
Oral solid dosage forms like tablets and capsules are the most common drug delivery formats. CMOs offer services in formulation, tableting, encapsulation, and packaging under GMP conditions.
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Powders & Granules
Powders and granules are oral solid formats used in sachets, suspensions, or direct consumption. CMOs offer blending, granulation, and filling services to ensure consistent quality and performance.
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Tablets & Capsules
Tablets and capsules are the most widely used oral dosage forms due to their stability and patient compliance. CMOs provide formulation development, compression, encapsulation, and packaging services under GMP standards.
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Semi-solid products
Semi-solid formulations like creams and ointments are used for topical drug delivery. CMOs offer formulation development, mixing, and GMP-compliant manufacturing for semi-solid products.
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Sterile injectables
Sterile injectables require precise manufacturing conditions. CMOs offer aseptic filling, lyophilization, and regulatory support for injectable formulations, including small molecules and biologics.
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Ampoules
Ampoules are sealed glass containers used for sterile injectables. CMOs provide ampoule washing, sterilization, filling, and sealing for various drug formulations.
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Liquid Vials
Liquid vials are used for injectable drug delivery, requiring sterile processing and filling. CMOs provide aseptic manufacturing, vial filling, and labeling in GMP-certified facilities.
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Contact Shandong Chenghui Shuangda Pharmaceutical Co. Ltd. for Contract Services Expertise

Connect with Shandong Chenghui Shuangda Pharmaceutical Co. Ltd., a leading pharmaceutical company from China. They offer specialized Drug Substance (CDMO/CRO), Drug Product (CMO), of which the services for CMO/CDMO include Powders & Granules, Tablets & Capsules, Ampoules. Contact Shandong Chenghui Shuangda Pharmaceutical Co. Ltd. for free and discover if they are the perfect partner for your pharmaceutical needs.

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.

Ampoules

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

Liquid Vials

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

Chenghui Shuangda Pharm


Established in 2014, Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is a leading Chinese manufacturer of active pharmaceutical ingredients (APIs) and advanced intermediates. The company operates 6 cGMP-compliant workshops and 9 automated production lines, delivering a monthly production capacity of 100 metric tons. To date, it has filed 22 products with the Center for Drug Evaluation (CDE) in China, registered 4 APIs in the United States Drug Master File (US-DMF), and submitted 7 applications for Certificates of Suitability (CEP) with the European Directorate for the Quality of Medicines (EDQM)‌.Supported by over 100 patents encompassing advanced synthesis and crystallization technologies‌, the company specializes in API manufacturing and offers integrated CDMO (Contract Development and Manufacturing Organization) and CRO (Contract Research Organization) collaborations. Its vertically integrated R&D and production platform underscores robust technical capabilities in delivering high-value .

 Business Scope:

Supply of APIs and intermediates
Co-development of APIs and intermediates
Custom synthesis of new products
CDMO business undertaking