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Hard Capsules CDMO Companies
Hard Capsules Contract Manufacturing Services

Your Trusted Partners for Hard Capsules Contract Manufacturing and Development

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Sidefarma
Spain

Sidefarma

Sidefarma SA

Sidefarma es un CMO especializado en la fabricación de lotes peque os y medianos para compa ías farmacéuticas de todo el mundo, en mercados regulados y siguiend

MARKETS: DIGEMID (Peru), Turkish Health Authorities, EDE (UAE), PMDA (Japan), EMA (EU), SFDA (Saudi Arabia), TGA (Australia), Health Canada (Canada), MHRA (UK)

BATCH SIZE: Small, Medium

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, CHEMICAL-SYNTHETIC

COMPLIANCE: EMA (EU GMP), UAE Ministry of Health & Prevention, ISO

CONTROLLED SUBSTANCES: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse

REGION: Europe

USE: Human

SERVICES: Analytical / QC services, Manufacturing services, Packaging, Quality Assurance services

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

Aenova Group - Location Killorglin, Ireland
Ireland

Aenova Group - Location Killorglin, Ireland

Aenova

Centro de Competencia para secado por atomización (spray drying) y pellets de liberación modificada.

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING, NUTRACEUTICALS, CHEMICAL-SYNTHETIC

COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), ISO, MFDS/KFDA (Republic of Korea GMP)

REGION: Europe

USE: Human, Veterinary

SERVICES: Analytical / QC services, Manufacturing services, Development services, Packaging, Quality Assurance services

MARKETS: PMDA (Japan), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia)

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

Aenova Group - Location Gronau, Germany
Germany

Aenova Group - Location Gronau, Germany

Aenova

Centro de competencia para sólidos convencionales y servicios clínicos.

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC

COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), FDA (cGMP)

MARKETS: EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU)

REGION: Europe

USE: Human, Veterinary

SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents

Aenova Group - Location Sisseln, Switzerland
Switzerland

Aenova Group - Location Sisseln, Switzerland

Aenova

Centro de competencia de sólidos convencionales complejos.

MARKETS: Turkish Health Authorities, ANVISA (Brazil), FDA (USA), Russian Health Authorities, MFDS (South Korea)

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, NUTRACEUTICALS, CHEMICAL-SYNTHETIC

COMPLIANCE: Roszdravnadzor (Russia GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO, MFDS/KFDA (Republic of Korea GMP)

REGION: Europe

USE: Human

SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

Adragos Pharma |  Athens
Spain

Adragos Pharma | Athens

Adragos Pharma

Socio global CDMO, ofreciendo servicios de Desarrollo y Fabricación para productos farmacéuticos.

MARKETS: ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), CDSCO (India), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, CHEMICAL-SYNTHETIC

COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), NSF, NMPA (China GMP), ISO, MFDS/KFDA (Republic of Korea GMP)

REGION: Europe

USE: Human

SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

CONTROLLED SUBSTANCES: High potential for abuse & medical use

PHARMALOOP S.L. - a Salvat Company
Spain

PHARMALOOP S.L. - a Salvat Company

Laboratorios Salvat

Fully integrated CDMO solutions for Blow-Fill-Seal (BFS), sterile multidose, non-sterile multi-dose, sachets, capsules and tablets.

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC

COMPLIANCE: EMA (EU GMP), FDA (cGMP), ISO

REGION: Europe

USE: Human

SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services

MARKETS: FDA (USA), EMA (EU)

THERAPEUTIC AREAS OF EXPERTISE (ATC): (V01) Allergens, (S) Sensory organs, (A) Digestive tract and metabolism

BSL (Biological Safety Level): 1

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)

FAES FARMA | DERIO facility
Spain

FAES FARMA | DERIO facility

FAES FARMA

Desarrollador y fabricante de medicamentos de uso humano

MARKETS: DIGEMID (Peru), ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)

BATCH SIZE: Small, Medium, Large

THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, COSMETICS, SERVICES, OLIGONUCLEOTIDES, CHEMICAL-SYNTHETIC

COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NMPA (China GMP), ECOVADIS, ISO, INVIMA, Health Canada (Canada GMP), MSPAS, MFDS/KFDA (Republic of Korea GMP), COFEPRIS

REGION: Europe

USE: Human

SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)

PRASFARMA
Spain

PRASFARMA

PRASFARMA

CMO/CDMO de citostáticos y productos de alta potencia

MARKETS: Turkish Health Authorities, ANVISA (Brazil), EMA (EU), SFDA (Saudi Arabia), NMPA (China), MHRA (UK)

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC

COMPLIANCE: EMA (EU GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), SFDA (Saudi Food & Drug Authority), ISO, TITCK (Turkish Health Authorities), ICH

REGION: Europe

BSL (Biological Safety Level): 3, 4

USE: Human

SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services

CONTROLLED SUBSTANCES: High potential for abuse & medical use

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)

THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
China

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site

Seacross Pharmaceutical Co Ltd

The R&D Center plays a fundamental role in supporting the development of both APIs and finished dosage forms.

MARKETS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)

BATCH SIZE: Small, Medium, Large

THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (V04) Diagnostic agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (B) Blood and blood forming organs, (V06) Nutrients

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, OLIGONUCLEOTIDES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC

COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), IFS, DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (China GMP), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Halal Research Council, INVIMA, Health Canada (Canada GMP), SQF (Safe Quality Food), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (Republic of Korea GMP), COFEPRIS

CONTROLLED SUBSTANCES: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse

BSL (Biological Safety Level): 3, 4, 1, 2

USE: Human

SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services

REGION: APAC

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

Adare Pharma | US
Spain

Adare Pharma | US

Adare Pharma Solutions

Adare Pharma es un CDMO global con instalaciones en EE.UU. y la UE, que ofrece desarrollo de productos llave en mano mediante experiencia en fabricación comerci

MARKETS: DIGEMID (Peru), ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, CHEMICAL-SYNTHETIC

COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NMPA (China GMP), ECOVADIS, ISO, Halal Research Council, Health Canada (Canada GMP), TITCK (Turkish Health Authorities), MFDS/KFDA (Republic of Korea GMP)

REGION: Europe, North America

USE: Human, Veterinary

SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals

Aenova Group - Location Regensburg, Germany
Germany

Aenova Group - Location Regensburg, Germany

Aenova

Centro de competencia sólidos de alta potencia (oncología) sólidos convencionales - semisólidos y líquidos especiales.

MARKETS: Turkish Health Authorities, ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia)

BATCH SIZE: Small, Medium, Large

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, COSMETICS, PARTICLE ENGINEERING, NUTRACEUTICALS, CHEMICAL-SYNTHETIC

COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), FDA (cGMP), SFDA (Saudi Food & Drug Authority), TITCK (Turkish Health Authorities), MFDS/KFDA (Republic of Korea GMP)

REGION: Europe

USE: Human, Veterinary

SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents

Adare Pharma | EU
Spain

Adare Pharma | EU

Adare Pharma Solutions

Global CDMO offering turnkey product development through commercial manufacturing expertise, focused on oral dosage forms.

MARKETS: DIGEMID (Peru), ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)

BATCH SIZE: Small, Medium, Large

THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (V01) Allergens, (M) Musculoskeletal system, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC

COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NMPA (China GMP), ECOVADIS, ISO, Halal Research Council, Health Canada (Canada GMP), TITCK (Turkish Health Authorities), MFDS/KFDA (Republic of Korea GMP)

REGION: Europe

USE: Human, Veterinary

SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

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Hard capsules remain a popular oral dosage form due to their versatility, ease of swallowing, and compatibility with a wide range of formulations. From standard gelatin capsules to HPMC and delayed-release systems, specialized hard capsules CDMO companies help pharmaceutical brands develop and produce high-quality products efficiently and compliantly.

By partnering with providers of hard capsules contract manufacturing, you gain access to flexible capsule technologies, GMP facilities, and proven expertise in handling APIs from early development through commercial launch.


How to Choose Hard Capsules CDMO Companies

Choosing the right hard capsules CDMO involves assessing capabilities across formulation, encapsulation, and regulatory compliance. Key factors to consider:

Capsule types offered: Gelatin, HPMC (vegetarian), acid-resistant, enteric-coated, and various sizes.

Formulation compatibility: Powders, pellets, granules, mini-tablets, and liquids.

Controlled-release technologies: Multi-particulate filling, modified-release beads, and matrix systems.

Analytical testing: Content uniformity, disintegration, dissolution, and moisture analysis.

Flexibility in batch size: Suitable for clinical trials or commercial-scale production.

Experience with high-potency or moisture-sensitive APIs.

A capable CDMO ensures your product is delivered in a capsule that meets performance, regulatory, and patient expectations.


Key Services Offered by Hard Capsules Contract Manufacturers

Comprehensive hard capsules contract manufacturing services typically include:

Formulation development: Powders, pellets, or combination fills.

Capsule selection and sourcing: Material, size, and release profile.

Filling and sealing: Hard gelatin and HPMC capsules.

Modified-release solutions: Enteric-coated pellets or timed-release beads.

Encapsulation of sensitive or potent compounds.

Stability studies and ICH-compliant storage.

Primary and secondary packaging.

Regulatory support: Global filings (IND, ANDA, EU dossiers).

These services enable pharma companies to bring capsule-based products to market efficiently.


Advantages of Partnering with Hard Capsules CDMO Companies

Working with trusted hard capsules CDMO companies provides key benefits:

Broad formulation compatibility: Suitable for solids and multiparticulates.

Improved speed to market: Integrated development and filling processes.

High flexibility: Capsule type and dosage form customization.

Regulatory confidence: Validated processes and inspection-ready facilities.

Support for lifecycle management: New strengths, release profiles, or combinations.

Whether for branded drugs, generics, or nutraceuticals, the right CDMO brings flexibility and scale.


Hard Capsules CDMO Companies

Some of the leading hard capsules CDMO companies include:

Lannett: Oral Solid Dose (OSD) and liquids. [See CDMO profile]

Pharmaloop (a Salvat company): Fully integrated solutions including BFS, sterile and non-sterile multi-dose, sachets, hard capsules, and tablets. [See CDMO profile]

Reig Jofre: FDF development and manufacturing in state-of-the-art facilities. [See CDMO profile]

Cenexi: Injectables manufacturing. [See CDMO profile]

FAES FARMA: Manufacturer of medicinal products including hard capsules. [See CDMO profile]

Cambrex: Early development of small molecule products in integrated DS/DP facilities. [See CDMO profile]

Skyepharma: Fully integrated FDF CDMO with expertise in oral technologies. [See CDMO profile]

Huiyu Pharmaceuticals Co., Ltd: Developer of complex forms including implants, OSD and sterile forms. [See CDMO profile]

Aenova Group: Competence center for solids and clinical services. [See CDMO profile]

I+Med: Developer of controlled-release drug products. [See CDMO profile]

Adragos Pharma: Manufacturing of oral liquids, semisolids, and OSD. [See CDMO profile]

Glatt Pharmaceutical Services GmbH Co. & KG: End-to-end CDMO for complex OSD. [See CDMO profile]

Darnytsia Kyiv: Manufacturer of oral liquids, semisolids, and OSD. [See CDMO profile]

Adare Pharma: Turnkey development and manufacturing for oral dosage forms. [See CDMO profile]

Sidefarma: Specialist in small- and medium-batch liquids, semisolids and OSD. [See CDMO profile]

Basic Pharma Manufacturing: Analytical testing, regulatory support, and OSD/sterile manufacturing. [See CDMO profile]


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Let MAI CDMO Help You Find the Right Hard Capsules CDMO Partner

At MAI CDMO, we connect pharma and biotech companies with leading hard capsules CDMO companies offering tailored hard capsules contract manufacturing solutions. Whether you’re working on a simple IR capsule or a complex multiparticulate system, we help you find the best-fit partner for your scale, speed, and quality goals.

Looking for flexible capsule manufacturing support? Contact us today and discover your best-fit CDMO.