Regulatory Support CDMOs

Benuvia Operations, LLC

United States

Benuvia Operations, LLC is a US-based specialized CDMO and API supplier focused on controlled substances. They pioneer work with cannabinoids, psychedelics, and traditional pharmaceuticals, offering a unified services platform from IND-enabling through commercial manufacturing. They hold DEA registrations and are FDA-registered for API manufacture, analysis, labeling, manufacturing, and packing. Their SYNDROS (Dronabinol) CII product demonstrates their controlled substance expertise.

Bespak

United Kingdom

Bespak is a specialist CDMO focused exclusively on inhaled and nasal drug delivery devices (pressurized metered-dose inhalers, dry powder inhalers, nasal sprays). Built on decades of experience designing, developing, and manufacturing inhaled drug delivery devices and drug products. FDA-registered with 6 inspections (2 NAI, 4 VAI). Operates from Holmes Chapel, UK facility with extensive device development and manufacturing capabilities.

Bilim Pharmaceuticals

Turkey

Bilim Pharmaceuticals is a major Turkish pharmaceutical company with comprehensive manufacturing capabilities across three production facilities in Gebze and Cerkezkoy. Provides contract manufacturing services alongside its own branded portfolio. Facilities produce a wide range of dosage forms including solid oral doses, liquids, semi-solids, sterile injectables, and inhalation products. Subject to international regulatory inspections and has clinical trials experience.

BioDuro (BioDuro-Sundia)

China

BioDuro-Sundia is a global CRDMO (Contract Research, Development and Manufacturing Organization) offering end-to-end integrated drug discovery and development services. The company provides comprehensive chemistry services (medicinal, peptide, synthetic, analytical, scale-up), biology/DMPK, drug substance process R&D and manufacturing, drug product formulation and manufacturing, and biologics services. Has acquired a US-based Phase III/commercial drug product manufacturing facility.

Bioiberica S.A.U.

Spain

Bioiberica S.A.U. is a Spanish life science company and global leader in the manufacturing of heparin and glycosaminoglycan-based APIs. Core products include heparin sodium, heparin calcium, enoxaparin sodium, chondroitin sulfate, and hyaluronic acid. FDA-registered for API manufacture with 12 inspections (11 VAI, 1 OAI). The company supplies APIs to pharmaceutical companies globally but also has its own branded products. Operates major manufacturing facilities in Spain.

BioInvent International AB

Sweden

BioInvent International AB is a clinical-stage biotech company focused on immuno-oncology antibody drug development, with an integrated contract manufacturing business unit (BioInvent Manufacturing) that has offered CDMO/CMO services since 1988. The cGMP manufacturing facility in Lund, Sweden produces monoclonal antibodies and fusion proteins using fully disposable technology in 40L to 1,000L bioreactors. Licensed by the Swedish Medical Products Agency and has French CIR accreditation. Has produced clinical-grade drug substance for trials in Europe, USA, Japan, Australia, and China.

Biolab (Thailand) – Biolab Company Limited

Thailand

Biolab Company Limited is a leading Thai pharmaceutical manufacturer with 45+ years of experience, producing pharmaceuticals, dietary supplements, and cosmeceuticals. The company operates a 24,000 sqm factory in Samut Prakan, Thailand with OEM/ODM contract manufacturing capabilities. Certified PIC/S GMP (Singapore HSA), EU GMP, ISO/IEC 17025, Halal, and Thai FDA Quality Award. Exports to 20+ countries.

Biological E Limited

India

Biological E Limited is an Indian biopharmaceutical company focused on vaccine development and manufacturing, with production capacity of up to 1 billion vaccines annually. They offer contract manufacturing for vaccines and biologics, with FDA-registered facilities performing analysis, API manufacture, labeling, manufacturing, and packing. Partners include Bavarian Nordic for chikungunya vaccine manufacturing.

Biomatrix Healthcare Pvt. Ltd.

India

BioMatrix Healthcare Pvt. Ltd. is an Indian pharmaceutical company established in 2007, headquartered in Ahmedabad, specializing in 100% export of pharmaceutical products to 40+ countries. Their manufacturing facility is WHO-GMP, EU-GMP certified and compliant with US-FDA, UK-MHRA, and ANVISA standards, with Health Canada site approval. Capacity: 5 billion tablets, 1 billion capsules, 24 million liquids, and 18 million dry syrups per annum. 1,000+ product registrations. Expanding with a new API manufacturing facility in Vadodara.

Biomay AG

Austria

Biomay AG is a fully integrated Austrian CDMO founded in 1984, specializing in GMP manufacturing of plasmid DNA (pDNA), messenger RNA (mRNA), and recombinant proteins. They operate two manufacturing sites in Vienna (Seestadt and mRNA Competence Center), offering end-to-end services from gene sequence to large-scale product supply. Biomay has manufactured 200+ GMP plasmid batches and offers personalized patient-specific batches. Member of the Alliance for mRNA Medicines (AMM). Expanding capacity tenfold with new production facility.

Bionova Scientific

United States

Bionova Scientific is a US-based biologics CDMO (part of Asahi Kasei Group) focused on the development and GMP manufacturing of monoclonal antibodies and other therapeutic proteins using mammalian cell culture processes. They offer cell line development, upstream/downstream process development, formulation development, pilot production, GMP manufacturing, and process characterization. Expanding into plasmid DNA (pDNA) manufacturing with a new facility in The Woodlands, Texas.

BioNTech

Germany

BioNTech SE is a global biotechnology company headquartered in Mainz, Germany, that develops and manufactures mRNA-based immunotherapies and vaccines. While primarily a pharmaceutical innovator, BioNTech operates extensive in-house GMP manufacturing capabilities for mRNA, antibodies, and cell therapies across multiple global sites. They pioneered the BioNTainer modular mRNA manufacturing solution. FDA-registered for API manufacture and analysis. Active in 10+ clinical trials across oncology and infectious disease.

Biophore India Pharmaceuticals

India

Biophore India Pharmaceuticals Pvt. Ltd. is a Hyderabad-based research-driven pharmaceutical company specializing in the development and manufacturing of niche active pharmaceutical ingredients (APIs) for global markets. Focus areas include oncology, contrast agents, peptides, injectable APIs, and orphan drugs. They have 110+ US DMFs, 150 global DMFs, 20+ CEPs, and 4 US FDA and EU approved manufacturing facilities. FDA-registered with 5 approved products (capsules, tablets). Partner relationships include Oakrum Pharma.

Bioplus Life Sciences Pvt Ltd

India

Bioplus Life Sciences Pvt Ltd is an Indian integrated biopharmaceutical company and CDMO, with 78 years of history operating in 50+ countries. They specialize in contract development and manufacturing of oral dosage forms, APIs, and nutraceutical products. The company is also developing a novel ophthalmology drug (7-MX for pediatric myopia control) through their subsidiary Theialife. Listed as a small molecule API manufacturer on industry databases.

Biose Industrie

France

Biose Industrie is a French CDMO specialized in microbiome therapeutics, established in 1951. They focus on manufacturing Live Biotherapeutic Products (LBPs) and Next-Generation Probiotics (NGPs) for pharmaceutical and consumer health markets. They combine aerobic and anaerobic microbiology expertise with industrial-scale GMP manufacturing. Investing EUR 80 million to expand capacity from 8,000L to 32,000L fermentation volume at their Aurillac site. They offer full CDMO services from process development to GMP drug product manufacturing.

BioTechnique LLC

United States

BioTechnique LLC is a full-service CRDMO based in York County, Pennsylvania, specializing in cytotoxic and therapeutic sterile injectable fill-finish services. The company provides services from investigational/clinical through to final marketed products, handling both small and large batch sizes. BioTechnique operates an FDA-registered facility with capabilities spanning sterile manufacturing, lyophilization, and high-potency compound handling.

BMI Korea

South Korea

BMI Korea is a South Korean CDMO offering contract development and manufacturing services spanning small molecule APIs, oral solid dosage forms, biologics, vaccines, and mRNA products. The company provides integrated services from formulation development through commercial-scale manufacturing with cGMP-compliant facilities.

Boehringer Ingelheim Biopharmaceuticals GmbH (BioXcellence)

Germany

Boehringer Ingelheim BioXcellence is the contract biopharmaceutical manufacturing arm of Boehringer Ingelheim, one of the world's largest pharmaceutical companies. BioXcellence offers end-to-end biologics CDMO services including mammalian cell culture, microbial fermentation, viral vector production, and aseptic fill/finish with extensive FDA, EMA, and PMDA regulatory approvals across multiple global facilities.

Bora Biologics

United States

Bora Biologics is a biologics-focused CDMO based in the United States offering contract development and manufacturing services for monoclonal antibodies, recombinant proteins, and other biologic drug substances and drug products. The company provides end-to-end biologics services from cell line development through cGMP manufacturing, analytical testing, and aseptic fill/finish.

Bora Pharmaceutical

Canada

Bora Pharmaceuticals is a global CDMO headquartered in Canada with manufacturing facilities across North America and Asia. The company offers comprehensive contract development and manufacturing services for oral solid dosages, sterile injectables, topicals, and liquids, serving both clinical and commercial supply needs with FDA and EMA approved facilities.

Boston Institute of Biotechnology (BIB)

United States

Boston Institute of Biotechnology (BIB) is a US-based full-service CDMO offering cGMP and non-GMP mammalian, microbial, gene therapy, and cell therapy services. The company features the world's first ultra-large bioreactor with 30,000L working volume capacity and provides end-to-end services from cell line development through commercial-scale cGMP manufacturing.

Brawn Laboratories Ltd

India

Brawn Laboratories Ltd is an Indian pharmaceutical manufacturer and WHO GMP-certified company that manufactures finished dosage forms including tablets, capsules, liquids, dry syrups, creams, ointments, and eye/ear drops. The company offers R&D and CDMO services alongside its own branded product portfolio, with manufacturing facilities in Faridabad near New Delhi and a presence in over 60 countries.

BSP Pharmaceuticals

Italy

BSP Pharmaceuticals is an Italian CDMO specializing in cytotoxic, ADC (antibody-drug conjugate), and non-cytotoxic sterile injectable manufacturing. The company provides development, clinical, and commercial supply services including API synthesis, ADC conjugation and fill/finish, and oral solid dose manufacturing, with FDA and EMA approved facilities near Rome.

Cadila Pharmaceuticals Ltd

India

Cadila Pharmaceuticals Ltd is one of India's largest privately-held pharmaceutical companies, operating as both a branded generics company and CDMO/CMO. The company covers the entire life science value chain including R&D, API manufacturing, formulations across 45 therapeutic segments, drug discovery, and contract manufacturing services including vaccines.

Cambrex

Canada

Halo Pharmaceuticals, acquired by Cambrex in 2018 for $425 million and later sold to SK Capital Partners in 2023, is a drug product CDMO specializing in oral solids, liquids, creams, sterile and non-sterile ointments, complex formulations, pediatric indications, and controlled substances. The company operates 430,000 square feet of GMP-compliant manufacturing space across Whippany, New Jersey and Montreal, Quebec, serving over 85 clients.

Canton Biologics Co., Ltd.

China

Canton Biologics Co., Ltd. is a biologics CDMO founded by Chinese returnee scientists at Guangzhou International Biological Island. The company provides integrated R&D and manufacturing services for biologics including CMC development, GMP manufacturing up to 2000L, analytical development, and aseptic fill/finish with GMP certifications from China, US, Japan, and Europe.

CARBOGEN AMCIS

CHina

CARBOGEN AMCIS is a leading CDMO offering drug substance and drug product development and manufacturing services from early development through commercialization. Part of the Indian Dishman Carbogen Amcis group, the company has facilities in Switzerland, France, UK, Netherlands, and China, specializing in complex small molecule APIs, ADC payloads, and sterile drug products.

Catalent Pharma Solution

Argentina

Catalent is a leading global CDMO trusted by pharma, biotech, and self-care companies to accelerate the development, manufacturing, and delivery of products that improve lives. With a worldwide network of facilities, advanced technologies, and deep expertise, Catalent provides integrated end-to-end solutions spanning oral dose, biologics, specialty therapies, cell and gene therapy, and clinical supply. The company partners with innovators from early-stage design through commercial manufacturing.

Celltrion

South Korea

Celltrion is a major South Korean biopharmaceutical company offering CDMO services for biologics, biosimilars, and small molecules. The company operates production capacities from 1,000L to 15,000L with a 98.5% batch success rate across 2,100+ cGMP drug substance batches, holding 400+ regulatory approvals in 90+ countries. Celltrion recently acquired Eli Lilly's Branchburg, New Jersey facility and launched Celltrion BioSolutions as a dedicated CDMO subsidiary, with plans to expand DS capacity to 132,000L by 2030.

Chemical Resources (CHERESO)

India

Chemical Resources (CHERESO) is an Indian company dedicated to the manufacture, export, and supply of standardized herbal extracts, dietary supplements, and select APIs such as Thiocolchicoside, Reserpine, and Colchicine. The company is a 100% export-oriented unit approved by the Government of India, with WHO-GMP, HACCP, NSF-GMP, ISO 9001/22000, Halal, and Kosher certifications. It holds multiple US DMFs and has an in-house R&D lab approved by DSIR.

Chemwerth

China

ChemWerth is a US-headquartered, family-owned full-service generic API development and supply company established in 1982. The company provides end-to-end services including new product development, compliance auditing, regulatory filing (500+ DMFs filed globally), and CMO management across 30+ FDA-approved manufacturing facilities in the US, Europe, India, and China. ChemWerth offers the CATALYST program for comprehensive API development and manufacturing.

Chime Biologics

China

Chime Biologics is a leading global CDMO focused on biologics and biosimilars, offering end-to-end services from cell line development through drug substance and drug product manufacturing. The company pioneered modular facilities with single-use bioprocessing technology and has partnerships with companies like MedPacto and Polpharma Biologics.

C.O.C. Farmaceutici Srl

Italy

C.O.C. Farmaceutici Srl (Content Group) is an Italian pharmaceutical CDMO specializing in contract development, manufacturing, and filling of liquid, gel, and lyophilized pharmaceuticals, medical devices, and cosmetics. The company operates three production plants in Italy (Sant'Agata Bolognese, Rovereto sul Secchia, and Pomezia) with 500+ employees, generating 108.3 million euros in turnover in 2025, with particular expertise in ophthalmic and respiratory products. The Pomezia facility (Tubilux Pharma) is FDA approved.

Cohance Lifesciences

India

Cohance Lifesciences is a global CDMO platform specializing in small molecule APIs, antibody-drug conjugates (ADCs), and nucleic acid chemistry, serving customers in nearly 60 countries with 80+ molecules in their portfolio. The company operates 20+ manufacturing and R&D facilities across India and the US, with multiple USFDA and EDQM-accredited sites, offering end-to-end solutions from drug discovery through commercialization including high-potent APIs (OEB 4 & 5), oligonucleotides, and finished dosage forms.

C‑Ray Therapeutics

China

C-Ray Therapeutics is a China-based global CRDMO dedicated to the development and manufacturing of innovative radiopharmaceuticals. The company operates a 10,000 sqm automated, intelligent, and digital Grade A production site with 13 high-standard radiopharmaceutical production lines, and has completed a Series A+ financing round exceeding $100 million.

CuraTeQ Biologics

India

CuraTeQ Biologics is an EU GMP-certified biopharmaceutical CDMO based in Hyderabad, India, and a subsidiary of Aurobindo Pharma. The company specializes in biosimilar development and manufacturing with a focus on oncology and immunology therapies, including monoclonal antibodies. CuraTeQ has filed multiple biosimilars with EMA and is building CDMO capabilities for contract biologics manufacturing.

Curida

Norway

Curida is a European CDMO headquartered in Oslo, Norway with over 50 years of GMP experience, specializing in biologics and liquid pharmaceutical formulations. The company offers contract development and manufacturing for monoclonal antibodies, nasal sprays, ophthalmic products, and sterile/non-sterile liquids using Blow-Fill-Seal technology. Curida operates multiple GMP-certified sites across Norway serving 40+ global partners.

Egis Pharmaceuticals PLC

Hungary

Egis Pharmaceuticals PLC is a Hungarian generic pharmaceutical company with over 110 years of history, now offering CDMO services through its Egis Pharma Services division. The company operates three production sites in Hungary (two in Budapest, one in Kormend) and manufactures APIs, tablets, injections, and galenic formulations including ointments, suppositories, and syrups. Egis specializes in highly potent API development and manufacturing using organic chemical synthesis on GMP-compliant multi-functional lines for oncology and rheumatic arthritis therapies.

Eirgen Pharma

Ireland

Eirgen Pharma is a leading CDMO headquartered in Waterford, Ireland, specializing in the development and manufacturing of high-potency oral solid dose (OSD) products and softgel capsules for human and companion animal health. The company offers end-to-end services from pharmaceutical development through clinical and commercial manufacturing with integrated packaging. Eirgen's globally-approved facilities feature advanced containment technologies for oncology, hormonal, and cytotoxic therapies.

Emcure Pharmaceuticals Limited

India

Emcure Pharmaceuticals Limited is a leading Indian pharmaceutical company and CDMO founded in 1981, headquartered in Pune, India, with operations spanning over 70 countries. Originally established as a CDMO, Emcure now operates 14 manufacturing facilities (including US FDA-approved sites) producing APIs, oral solid dosage forms, injectables (including liposomal and lyophilized), biotherapeutics, and vaccines. The company specializes in complex generics, chiral molecules, high-potency APIs, and novel drug delivery systems including lipid nanoparticles and long-acting injectables.

Ethypharm

China

Ethypharm is a leading mid-size international specialty pharmaceutical company and CDMO with 5 manufacturing plants across France, UK, and Spain. The company specializes in oral solid dosage forms, sterile injectables in ampoules, pre-filled syringes and IV bags, with particular expertise in high potent APIs and controlled substances including opioids and psychotropics.

Fresenius Kabi iPSUM S.r.l.

Italy

Fresenius Kabi iPSUM S.r.l. is the Italian subsidiary of Fresenius Kabi, a global healthcare company with significant CDMO operations specializing in lifesaving medicines for critically and chronically ill patients. The company has extensive FDA-registered manufacturing facilities with 405 FDA-approved products, and provides contract development and manufacturing services for injectable, infusion, and other sterile pharmaceutical products.

Gland Pharma

Belgium

Gland Pharma is one of the largest generic injectable manufacturing companies globally, established in Hyderabad, India in 1978. The company operates under a B2B/CDMO business model with four cGMP-compliant formulation facilities and four API facilities, supplying products across 60 countries. It focuses on sterile injectables, oncology, and ophthalmics, including complex injectables and 505(b)(2) filings.

Gracure Pharmaceuticals Ltd

India

Gracure Pharmaceuticals Ltd is an Indian pharmaceutical company offering contract development and manufacturing services for finished dosage forms. The company manufactures oral solid dosage forms, liquids, and semi-solid products from WHO GMP and EU GMP-certified facilities, serving regulated and semi-regulated export markets. It provides formulation development, analytical testing, and commercial-scale manufacturing.

Grifols (Grifols Partnership)

Spain

Grifols Partnership is the CDMO arm of Grifols, a Spanish multinational with over 100 years of pharmaceutical experience, specializing in added-value small molecule injectable products manufactured in flexible bags and vials. The company operates FDA-approved manufacturing facilities and serves mid-size, large, and generic pharmaceutical companies with sterile parenteral drug products, including terminal sterilization and Form-Fill-Seal processes.

Grupo Ferrer Internacional, S.A. (Ferrer)

Spain

Grupo Ferrer Internacional (Ferrer) is a Spanish pharmaceutical company with certified production plants in Spain and the United States that manufactures chemical substances, APIs, and finished pharmaceutical products both for its own portfolio and for third parties under contract. The company's FDA registration is for API manufacture and analysis, and its website explicitly states it manufactures for third parties.

HALIX

Netherlands

HALIX is a biologics CDMO based in Leiden, Netherlands, specializing in end-to-end development and GMP manufacturing of viral vectors, vaccines, and recombinant proteins. The company operates a 6,700 square meter cGMP facility at the Leiden Bio Science Park with 10 clean rooms and 7 bioreactors. HALIX successfully manufactured the AstraZeneca COVID-19 vaccine at commercial scale and serves over 75 customers with a 90% retention rate.

Hanmi Pharm. Co. Ltd

South Korea

Hanmi Pharmaceutical is a major South Korean pharmaceutical company providing comprehensive CDMO services across the entire pharmaceutical lifecycle. The company operates through Paltan Smart Plant (producing 6+ billion chemical drug tablets annually), Pyeongtaek Bioplant (FDA-approved biopharmaceutical manufacturing with 12,500L bioreactors), and Hanmi Fine Chemical (API and raw materials including mRNA cap analogs, NTP, and lipids). Hanmi has partnerships with global pharma companies including Lilly, Roche, and Sanofi.