Immaculé

One Stop Solution
Concept to Commercialization

Immaculé

One Stop Solution
Concept to Commercialization

Who We Are

Immacule Lifesciences is the fastest growing, and leading one stop solution for liquid and lyophilized injectables. Our foundation is built upon our unwavering dedication to innovation, quality, and enduring partnerships. Our advanced manufacturing facility boasts world-class technology and is complemented by years of expertise and research, positioning us as the preferred business partner for pharmaceutical companies all across the globe.

Innovation

Immacule provides world-class expertise in sterile products with consistency in quality, delivery and competitive pricing.

Quality

Our state-of-the-art manufacturing facility is compliant with international regulatory agencies and has a robust quality system.

Partnerships

Years of research and experience have made us an attractive and reliable partner for pharmaceutical companies all across the globe.

Innovation

Immacule provides world-class expertise in sterile products with consistency in quality, delivery and competitive pricing.

Quality

Our state-of-the-art manufacturing facility is compliant with international regulatory agencies and has a robust quality system.

Partnerships

Years of research and experience have made us an attractive and reliable partner for pharmaceutical companies all across the globe.

Our Evolution

2012

Inception

2015

Ukraine/INVIMA Approvals Commercial Supply to the ROW market

2016

UK-MHRA/ANVISA Approvals Commercial Supply to the EU Market

2017

Scale Up/Exhibit Batches Manufacturing for the US Market

2018

Filing and approval of the first two ANDAs

2019

USFDA Approval with Zero ‘483′

2022

USFDA Renewal/EU GMP Renewal

2023

Sterile Capacity Expansion Investment: USD 100 million

2024

Completion of the Sterile Capacity Expansion OPHTHALMIC/ONCO/PFS/CARTRIDGE capabilities

The Future

The Future of
Immacule

In its stride towards the future, Immacule is marking its entry into:

Ophthalmic

Oncology Injectables

Pre-Filled Syringe and Cartridges

F&AD

Formulation and Analytical Development

Immacule Lifesciences is committed to revolutionizing the pharmaceutical industry and spreading health and happiness across the globe. Our Formulation and Analytical Development (F&AD) pipeline, developed jointly with our external partners, is loaded with innovative gems that have high medical utility in the near future.

30M
Liquid Vials/ Ampoules
12M
Lyophilized Vials

Group Clientele

Regulatory Approvals

Contact Us