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Ophthalmic CDMO Companies
Ophthalmic Contract Manufacturing Services

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Applied Filters:Sterile forms (ophtalmic, nasal, otic)×Ophtalmic dispensers×FDF / DRUG PRODUCTS×Clear All
Showing 11 facilities
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.

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

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

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

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

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

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

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

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

REGION: APAC

BATCH SIZE: Large, Small, Medium

USE: Human

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.

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MARKETS: EMA (EU), FDA (USA)

REGION: Europe

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

BATCH SIZE: Large, Small, Medium

USE: Human

BSL (Biological Safety Level): 1

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

THERAPEUTIC AREAS OF EXPERTISE (ATC): (S) Sensory organs, (V01) Allergens

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)

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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Tubilux Pharma: registered office; manufacturing facility.

Location available after registration

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COSMETICS manufacturing site

MAI network supplier

Developer and manufacturer of new drug products with control realease technologies.

Location available after registration

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COSMETICS manufacturing site

MAI network supplier

Israeli CDMO specialized in the development and GMP manufacturing of complex synthetic drug products and chemistry-based medical devices.

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HBM Pharma
Slovakia

HBM Pharma

Hbm Pharma

EU-GMP-certified CMO based in Martin, Slovakia. The company provides manufacturing and packaging servicesfor sterile pharm. products and solid oral dosage forms

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MARKETS: EMA (EU), NMPA (China), Health Canada (Canada), ANVISA (Brazil), COFEPRIS (Mexico), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, TGA (Australia)

COMPLIANCE: ISO, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), ANVISA (Brazil)

USE: Human

BATCH SIZE: Large, Small, Medium

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

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

CONTROLLED SUBSTANCES: High potential for abuse & medical use

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES

REGION: Europe

Lifecore Injectables CDMO
United States

Lifecore Injectables CDMO

Lifecore Biomedical

CDMO that manufactures clinical & commercial sterile injectable drug products.

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

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

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

COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

CONTROLLED SUBSTANCES: Lowest potential for abuse

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

REGION: North America

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

FAES FARMA | DERIO facility
Spain

FAES FARMA | DERIO facility

FAES FARMA

Developer and manufacturer of human medicinal products.

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

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

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

USE: Human

BATCH SIZE: Large, Small, Medium

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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)

REGION: Europe

JAFRAL
Slovenia

JAFRAL

JAFRAL

Integrated biotechnology facility providing R&D, non-GMP and GMP manufacturing, QC testing, and fill & finish services for advanced biologics.

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

COMPLIANCE: ICH, FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP), SQF (Safe Quality Food)

MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia)

BSL (Biological Safety Level): 1, 2

CATEGORY / PRODUCT: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS

USE: Human, Veterinary

BATCH SIZE: Large, Small, Medium

CONTROLLED SUBSTANCES: Lowest potential for abuse

THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use, (D) Dermatologicals, (V06) Nutrients, (R) Respiratory system, (A) Digestive tract and metabolism

REGION: Europe

Aenova Group - Location Latina, Italy
Italy

Aenova Group - Location Latina, Italy

Aenova

Competence Center animal health products and sterile technologies.

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MARKETS: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities

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

REGION: Europe

COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU GMP)

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

BSL (Biological Safety Level): 1, 2

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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

Adragos Pharma | Halden
Norway

Adragos Pharma | Halden

Adragos Pharma

We specialize in the manufacturing of IV bags, plastic ampoules and vials using Blow-Fill-Seal (BFS) technology and other dosage forms.

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

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

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

REGION: Europe

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

BATCH SIZE: Large, Small, Medium

USE: Human

THERAPEUTIC AREAS OF EXPERTISE (ATC): (D) Dermatologicals, (V06) Nutrients, (A) Digestive tract and metabolism

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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

Adragos Pharma | Athens
Greece

Adragos Pharma | Athens

Adragos Pharma

Specializes in the development of Value Added Medicines and has been recently upgraded with HPAPI capabilities.

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

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

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

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

REGION: Europe

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

BATCH SIZE: Large, Small, Medium

USE: Human

CATEGORY / PRODUCT: SERVICES, FDF / DRUG PRODUCTS

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The ophthalmic drug market demands precise formulation, absolute sterility, and specialized delivery systems. From eye drops and gels to intravitreal injections, developing and manufacturing ophthalmic products requires specific capabilities that only experienced ophthalmic CDMO companies can offer.

Whether you´re scaling a preservative-free eye drop or developing a complex sustained-release formulation, working with a partner offering full-spectrum ophthalmic contract manufacturing services ensures safety, efficacy, and compliance — from early development through commercialization.

How to Choose Ophthalmic CDMO Companies

When evaluating ophthalmic CDMO companies, look for the following key capabilities:

  • Sterile manufacturing facilities with isolators or RABS

  • Experience with various dosage forms: eye drops, gels, ointments, inserts, and injections

  • Preservative-free and multi-dose systems with microbial ingress testing

  • Particle control and clarity testing specific to ophthalmic standards

  • Regulatory compliance with FDA, EMA, and other global agencies for ophthalmic formulations

  • Secondary packaging and labeling suited for ophthalmic formats

Ophthalmic manufacturing is highly regulated and niche, choosing a CDMO with true category expertise is essential to avoid costly setbacks.

Key Services Offered by Ophthalmic Contract Manufacturers

High-quality ophthalmic contract manufacturing partners typically offer:

  • Formulation development for solutions, suspensions, gels, and ointments

  • Sterile filling in bottles, tubes, or prefilled syringes

  • Preservative-free system design with filter integrity testing

  • Blow-Fill-Seal (BFS) and single-dose vial manufacturing

  • Intravitreal injection formulation and aseptic filling

  • Stability studies and ICH testing

  • Regulatory dossier support for ophthalmic drug submissions

  • Packaging, serialization, and cold chain storage

These services ensure that your ophthalmic product meets the highest quality and sterility standards.

Advantages of Partnering with Ophthalmic CDMO Companies

Collaborating with specialized ophthalmic CDMO companies brings significant advantages:

  • Expertise in ocular delivery systems and formulation

  • Minimized contamination risk via advanced aseptic environments

  • Support for complex formulations, including viscosity modifiers and micronized APIs

  • Faster regulatory approval with ophthalmic-specific documentation

  • Flexibility in batch sizes for clinical trials, orphan indications, and large-scale production

The right CDMO ensures your product is not only safe and effective but also optimized for patient use and regulatory compliance.

Ophthalmic CDMO Companies

Some of the leading ophthalmic CDMO companies include:

  • Liof Pharma: Aseptic manufacturing and lyophilization of biologics and injectable drugs. [See CDMO profile]
  • I+Med: Developer and manufacturer of new drug products with controlled-release technologies. [See CDMO profile]
  • Pharmaloop (a Salvat company): Fully integrated CDMO solutions for Blow-Fill-Seal (BFS), sterile multidose, ophthalmic, non-sterile multidose, sachets, capsules, and tablets. [See CDMO profile]
  • Ophtapharm (a Sentiss company): Ophthalmic and otic solutions, suspensions, emulsions, ointments, and gels. FDA-approved site. [See CDMO profile]
  • Huiyu Pharmaceuticals Co., Ltd: Development and manufacturing of complex, high-value dosage forms including implants, oral solids (OSD), and sterile formulations. [See CDMO profile]
  • Content Group: Manufacturing of sterile dosage forms (ophthalmic, nasal, otic) and finished drug products (FDF). [See CDMO profile]
  • Ascendia Pharmaceutical Solutions: GMP-certified CDMO providing advanced sterile and non-sterile pharmaceutical manufacturing, formulation development, and analytical testing services. [See CDMO profile]

Related Information

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Let MAI CDMO Help You Find the Right Ophthalmic CDMO Partner

At MAI CDMO, we help you identify and connect with the most experienced ophthalmic CDMO companies based on your formulation type, regulatory pathway, and market goals. Whether you´re developing a novel ocular therapy or scaling a mature product, our network of ophthalmic contract manufacturing experts will ensure you meet timelines and maintain quality from batch one to global launch.

Need a reliable partner in ophthalmics? Contact us today and let’s find the right CDMO for your needs.