Lyophilized Product CDMOs

Nippon Shokubai Co., Ltd. (Health & Medical Business)

Japan

Nippon Shokubai's Health & Medical Business division operates as a CDMO specializing in oligonucleotide and peptide API manufacturing. The company has two oligonucleotide synthesis/purification lines and one peptide line, making it one of Japan's largest manufacturers in this sector. A tenfold GMP capacity expansion (several kg/batch) is planned for 2027 to meet growing global demand for nucleic acid drug APIs.

Northway Biotech

Lithuania

Northway Biotech is a global end-to-end biologics CDMO specializing in protein-based biologics and gene therapies. The company operates state-of-the-art facilities in Vilnius, Lithuania (EU) and Waltham, Massachusetts (US), with 20+ years of technical expertise. Northway offers cell line development, process development, analytical development, and cGMP manufacturing of drug substances and drug products using both mammalian cell culture and microbial fermentation technologies.

OneSource Specialty Pharma Limited

India

OneSource Specialty Pharma Limited (formerly Stelis Biopharma Limited) is India's first specialty pharma pure-play CDMO, offering multimodal end-to-end capabilities across drug-device combinations, complex sterile injectables, biologics, and soft gelatin capsules. The company operates five state-of-the-art facilities in Bengaluru with 35 approved ANDAs and 19 commercialized drug products in the US market.

SGS

Brazil

SGS Integrated CDMO Solutions is the contract development and manufacturing division of the global testing and inspection company SGS SA. Established in 2002 with a specialized UK-based CDMO site (MHRA and FDA inspected), SGS provides formulation development, API manufacturing, sterile fill/finish, lyophilization, and analytical services. A new 55,000 sq ft cGMP facility in Hudson, NH expands their North American capabilities across Phase I-III clinical trials and commercial supply.

Sharp Sterile Manufacturing

United States

Berkshire Sterile Manufacturing (now Sharp Sterile Manufacturing, acquired by Sharp in 2023) is a specialist CDMO providing sterile injectable development and manufacturing services from its isolator-based facility in Lee, Massachusetts. All fills are 100% isolator-based using Colanar fillers, supporting clinical through small-to-mid-scale commercial production of vials, syringes, and cartridges. FDA-inspected with 8 inspections (7 NAI, 1 VAI), demonstrating strong regulatory compliance.

Siegfried Group

China

Siegfried Group is a leading global CDMO with 150+ years of pharmaceutical and chemical heritage, operating 13 production sites across Switzerland, Germany, Spain, France, Malta, the USA, and China. The company provides integrated services from early-phase API development through commercial-scale drug substance and drug product manufacturing, including exclusive synthesis, generic APIs, controlled substances, HPAPI handling, sterile formulations, and viral vector manufacturing through subsidiary DINAMIQS. In January 2026, Siegfried announced acquisition of additional US-based small molecule drug substance capacity.

SmaBio Labs

United States

SmaBio Labs is a USA-based CDMO located in Research Triangle Park, North Carolina, delivering end-to-end drug development solutions from molecule discovery to market launch. They specialize in Chemistry Manufacturing and Control (CMC) services for small molecules, peptides, biologics, and complex APIs. Their capabilities include analytical services (IND/ANDA support, method development and validation, ICH stability testing, HPLC/UPLC, LC-MS, ICP-MS, NMR, XRPD), drug discovery and process development, API manufacturing (kg-scale cGMP), product development (formulation for oral solid dose, injectables, lyophilized products), and clinical trial material manufacturing (Phase I-III). FDA registered for analytical services. They support HPAPI compounds up to OEB 5.

VUAB Pharma a.s.

Czech Republic

VUAB Pharma a.s. is a traditional Czech pharmaceutical manufacturer with over 75 years of experience, specializing in contract development and manufacturing of APIs and finished dosage forms. Part of the SAFICHEM group, the company operates multiple production centers including API manufacturing in Roztoky u Prahy, API in Brno, and biotechnology in Ceske Budejovice. VUAB is FDA-registered for API manufacturing.

Advaxia Biologics is a CDMO near Rome, Italy, specializing in adenovirus vaccine development and cGMP manufacturing. With over 10 years of biologics expertise and a 100% batch approval rate, Advaxia provides fully integrated services from expression systems and process development to analytical development and GMP manufacturing, and is EMA, FDA, and AIFA compliant.

Contract Packaging Resources is a member of the Aenova Group, a worldwide leading CDMO for the pharmaceutical and healthcare industry. The Aenova Group provides comprehensive pharmaceutical manufacturing including solid dosage forms, sterile fill and finish, semi-solids, non-sterile liquids, softgels, gummies, and packaging services. The Latina site in Italy serves as the central sterile manufacturing facility with capacity for over 100 million units per year, handling biologics including monoclonal antibodies, peptides, and vaccines with isolator technology.

Bushu Pharma is Japan's premier CDMO with over 25 years of experience, specializing in contract manufacturing of solid dosage formulations, sterile injectables, lyophilized products, and prefilled syringes for both clinical trial supplies and commercial products. The company operates five factories in Japan with GMP certifications from 56 countries including FDA, EMA, and PMDA, serving over 90 pharmaceutical companies globally with nearly 50% of sales from foreign-affiliated clients.

Cobra Biologics is an international CDMO specializing in plasmid DNA, viral vectors, and aseptic pharmaceutical manufacturing, now part of Charles River Laboratories following the acquisition of Cognate BioServices. The company operates facilities in the UK and Sweden (Matfors), providing clinical and commercial-scale manufacturing of gene therapy products, with expanded viral vector suite capabilities and collaborations in COVID-19 vaccine manufacturing.

CordenPharma is a full-service CDMO providing integrated development and manufacturing of APIs, drug products, and lipid excipients across a global network of cGMP facilities in Europe and North America. The company offers capabilities spanning peptides, oligonucleotides, highly potent and oncology compounds, small molecules, injectables, lipid nanoparticles (LNPs), and oral solid dosage forms. CordenPharma is investing over EUR 500M in a new peptide manufacturing facility in Muttenz, Switzerland, and expanding its Colorado site for large-scale peptide production.

Shenzhen Hybio Pharmaceutical Co., Ltd. (Hybio) is a Chinese pharmaceutical company founded in 1998, specializing in peptide drug R&D, manufacturing, and commercialization with a CRDMO division. The company focuses on peptide APIs (including semaglutide) and sterile injectable formulations, with products sold in 30+ countries. Hybio has 7 FDA-registered facilities and a strategic partnership with Dr. Reddy's for peptide API supply, and recently partnered with Huawei for AI-driven drug development.

Oncotec Pharma Produktion GmbH is a German CDMO specializing in the development and aseptic manufacturing of cytostatic (anticancer) drugs. Founded in 1997, the company provides full-service contract manufacturing from lab-scale development through commercial production, with approximately 2,300 m2 of cleanroom space and isolator-protected production lines at its Dessau-Rosslau facility.

Pace Life Sciences is a division of Pace Analytical Services LLC, operating as a full-service CDMO/CRO network across the United States. The company supports drug development across the entire lifecycle from preclinical research through commercialization, specializing in small molecules, biologics (proteins, peptides, monoclonal antibodies, ADCs), nucleic acids (oligonucleotides, mRNA, plasmid DNA), and gene therapies. Recognized by PharmaSource as a Top CDMO in the United States. Operates 9+ strategically located sites including a sterile fill-finish Center of Excellence in Salem, NH.

PharmIdea is a Latvian CDMO located in Olaine, Latvia, specializing in sterile drug development, commercial production, and worldwide supply of pharmaceutical products. The company focuses on sterile drugs in vials, offering contract manufacturing services including product development. PharmIdea has completed CTDs for out-licensing and provides contract manufacturing of sterile injectables such as Levosimendan concentrate for solution for infusion (small batch), Caspofungin, and Carbetocin. The company has partnered with Lidds for manufacturing NZ-TLR9 formulation against solid tumors.

Sunny Pharmtech Inc. is a Taiwan-headquartered integrated specialty pharmaceutical CDMO specializing in high-potency APIs and drugs, including small molecules, peptides, and ADC linker-payloads. The company develops complex, high-barrier, niche drugs including ANDAs and 505(b)(2) filings, with state-of-the-art facilities offering OEB 5 containment and capabilities from early-stage formulation development to commercial manufacturing.

Vibalogics is a specialized global CDMO for virotherapy manufacturing, now operating as Recipharm Advanced Bio after acquisition by Recipharm AB. The company offers process and analytical development, GMP manufacturing of viral vectors, oncolytic viruses, and advanced therapies. Capabilities include xRNA therapies, viral vectors (AAV, lentivirus), microbial/live biotherapeutic products, recombinant proteins, plasmid DNA, and lipid nanoparticles. Major $50M expansion of Cuxhaven facility (500L manufacturing line) completed. 118,000 sq ft GMP facility in Massachusetts (US) also completed.

Zambon is an Italian multinational healthcare group founded in 1906 with EUR 899 million in revenues and 2,768 employees. The group operates as both a pharmaceutical company (Zambon Pharma) and a CDMO, offering contract development and manufacturing services ranging from development through commercial production. Manufacturing plants in Vicenza (Italy), Cadempino (Switzerland), Haikou (China), and Barueri (Brazil) supply 87 countries. Also includes Zach System (API custom synthesis) as its chemical division.

Lisapharma S.p.A. is an Italian pharmaceutical company specializing in the contract manufacturing of sterile injectable products, located in Erba (Como), Italy. The company provides sterile fill/finish services for vials, syringes, and cartridges, with capabilities in lyophilization. The website domain lisapharma.com is no longer active, but the company operates from lisapharma.it and is FDA-registered for manufacturing.

Pii (Pharmaceutics International, Inc.), acquired by Jabil in February 2025, is a US-based CDMO specializing in complex formulations. With over 30 years of experience and 300+ scientists and support staff, Pii handles potent compounds, complex formulations, aseptic injectables, complex oral dosage forms, and high-potency soft gels. Offers phase-appropriate support from early development through commercial manufacturing. Located in Hunt Valley, Maryland. 100% FDA licensed with 5 drug product approvals in 2023.