Leading API Manufacturer

Inke develops and manufactures high-quality APIs and HPAPIs with advanced synthesis, micronisation, and containment expertise across respiratory, CNS, and ophthalmic therapies.

With a legacy dating back to 1980, Inke has been at the forefront of API development, pioneering innovative synthetic routes and polymorph design. Inke’s manufacturing capabilities are built around two state‑of‑the‑art cGMP facilities located near Barcelona. Our Castellbisbal Manufacturing Site focuses on inhalation, micronization and large‑scale chemical synthesis for global API supply, while the Avinyonet del Penedès Manufacturing Site is designed for high‑containment HPAPI production and advanced process development. Together, both sites provide a robust, flexible and fully compliant industrial platform that supports our customers across respiratory, CNS and ophthalmic APIs.

Our Facilities

Inke Castellbisbal Manufacturing Site - (Inke CB)

Our Castellbisbal facility is a versatile, cGMP-certified plant designed for the production of respiratory, CNS, and specialty APIs. Equipped with advanced technology and stringent containment measures, it offers flexibility and scalability for complex synthesis and micronisation processes. Key features include:

  • 25+ years of expert in-house micronisation with custom PSD control
  • 20+ years of successful FDA Inspections
  • Reaction capacity: 28 m³ (reactors from 60 L to 6,300 L)
  • Temperature range: -70ºC to 200ºC; pressure up to 20 bar
  • Expertise in hydrogenation, reduction, oxidation, and organometallic chemistry
  • 17,600 m² of cGMP facility
  • Handle APIs with OEL’s up to 1 µg/m³

Our Facilities

Inke Avinyonet Manufacturing Site - (Inke AV)

Our second facility is dedicated to the development and production of ophthalmic HPAPIs under the highest containment standards. Combining advanced synthesis and purification technologies, it ensures operator safety and product integrity throughout the process. Key features include:

  • OEB 4 containment level (SafeBridge®), <30 ng/m³
  • Reactors from 50 ml to 20 L
  • High-containment suites with isolators and downflow booths.
  • Advanced purification technologies: HPLC, UPLC, SFC, and preparative chromatography.
  • EU-GMP certified, ANVISA approval
  • ISO 8 Clean Rooms

Advanced Manufacturing Capabilities

Our facilities are designed to handle complex synthesis and high-containment processes with precision and scalability. The Castellbisbal site offers a total reaction capacity of 28 m³, supporting a wide range of organic reactions under controlled conditions, including hydrogenation, reduction, oxidation, and organometallic chemistry. With over 25 years of in-house micronisation expertise, we deliver custom Particle Size Distribution (PSD) to meet the most demanding formulation requirements.

Inke Ophthalmics complements these capabilities with specialized infrastructure for Highly Potent APIs (HPAPIs), operating under OEB 4 containment standards. Equipped with isolators, downflow booths, and advanced purification technologies such as HPLC, UPLC, and SFC, this facility ensures the highest level of safety and product integrity for ophthalmic therapies.

Canada, USA & Mexico

For detailed information on this market, please reach out to Maite Pascual.

mtpascual@inke.es

Japan

For detailed information on this market, please reach out to Mónica Capón

mcapon@inke.es

Africa

Turkey, South Africa, MENA (Egypt, Algeria, Morocco & Tunisia)

For detailed information on this market, please reach out to Maite Pascual.

mtpascual@inke.es

India, Bangladesh & Pakistan

For detailed information on this market, please reach out to Maite Pascual.

mtpascual@inke.es

Inke Avinyonet Manufacturing Site - (Inke AV)

Main Offices:

Avinguda Diagonal, 605 6D,
08028 Barcelona, Spain

Inke Ophthalmics Manufacturing Site:

C/ Tramontana 3
08793 Avinyonet del Penedès, Barcelona, Spain

contact-inke@inke.es

Inke Castellbisbal Manufacturing Site - (Inke CB)

Main Offices:

Avinguda Diagonal, 605 6D,
08028 Barcelona, Spain

Manufacturing Site:

Area Industrial del Llobregat,
Argent 1, 08755 Castellbisbal
Barcelona, Spain

GPS address
contact-inke@inke.es

Inke US Office

53 State Street, Suite 500
Boston, MA, 02109.

GPS address

LATAM

Argentina & Brazil

For detailed information on this market, please reach out to Jorge Llorens.

jllorens@inke.es

Europe

For detailed information on this market, please reach out to Helena Kalaitzopoulos.

hkalaitzopoulos@inke.es

Spain

For detailed information on this market, please reach out to Maite Pascual.

mtpascual@inke.es

Asia & Oceania

China, Korea, Taiwan and Southest Asia (Vietnam, Philippines, Thailand & Malaysia), Australia & New Zealand

For detailed information on this market, please reach out to Harry Yuan.

hyuan@inke.es

Our versatile cGMP facilities are engineered to meet the highest pharmaceutical standards in respiratory, CNS and ophthalmic APIs.

cGMP Dual-Site Excellence

two state-of-the-art facilities in Barcelona ensuring end‑to‑end API and HPAPI manufacturing.

Reaction Capacity & Scale

Total reaction capacity of 28 m³ (60 L to 6,300 L) with controlled temperature (‑70/‑75ºC to 200ºC) and pressure (up to 20 bar).

Micronisation & Particle Engineering

25+ years of in‑house micronisation with custom PSD to align with Finished Dosage Form requirements.

High-Containment Capabilities

OEB 4 operations for HPAPIs, ISO 8 clean rooms, isolators and downflow booths to ensure product integrity and operator safety.

Advanced Purification & Analytics

Integrated HPLC, UPLC, SFC and comprehensive QC for robust in‑process control and release testing.

Regulatory & Quality Leadership

EU‑GMP and FDA track record (plus ISO 9001 & ISO 14001); ANVISA approval supporting global market access.

Uncompromising Quality Standards

Our commitment to excellence is reflected in rigorous inspections and internationally recognized certifications. Both Inke facilities operate under the most stringent Good Manufacturing Practice (GMP) standards and are regularly audited by leading health authorities, including EU-GMP, FDA (last inspection April 2019), KFDA, PMDA, and ANVISA.

In addition, we hold ISO 9001 and ISO 14001 certifications, supported by robust quality, health & safety, and environmental policies that ensure compliance and sustainability across all operations.

Discover our ESG vision

Wide variety of chemical reaction capabilities

Reactions

  • Organometallic chemistry
  • Grignard reactions
  • Organolithium
  • Cyclization
  • Friedel-Crafts
  • High temperature reactions
  • Hydrogenation (catalytic)
  • Oxidation (H2O2, peracid…)
  • Reduction with hydrides

Handling of hazardous chemicals

  • Alkylating agents
  • Bromine
  • Chlorinating agents (SO2Cl2, SOCl2, POCl3, PCl5)
  • Hydrochloric acid gas
  • Lewis acids (BF3, ACl3…)
  • Metal hydride

Explore our capabilities in Inhalation, CNS, and Ophthalmic APIs

Discover how Inke combines complex synthesis, micronisation, and high-containment expertise to deliver high-quality APIs and HPAPIs for global pharmaceutical partners.

Get in touch to discuss your manufacturing needs