Immacule Lifesciences

About Us

WHY IMMACULE

Founded in 2012, today, Immacule Lifesciences has become a renowned name in the pharmaceutical industry. At Immacule, our dedicated team of scientists is here to provide you with customized services, supported by our extensive network of capabilities and resources. No matter where you are, as an end-to-end pharmaceutical service provider and partner we offer quality, speed and value by combining our technical competencies and cost-effective solutions.

We are backward integrated in pharmaceutical research and development and our focus ranges from the classification and development, to the commercialization of complex liquid (aqueous/non aqueous) and lyophilized injectables in vials and ampoules, with robust capabilities for terminal sterilization as well as aseptically filled injectables.

As a CDMO we are rapidly capturing the highly competitive sterile US market, in collaboration with our partners we have received 15 ANDA approvals, have 14 ANDAs under review and a filing target of 50+ by 2025.

Immacule is focusing on First to File 505(b)(2) submissions, NCEs & complex generics niche products scale-up, exhibit batches & commercial manufacturing support services to its global clients.

Why Immacule

Founded in 2012, today, Immacule Lifesciences has become a renowned name in the pharmaceutical industry. At Immacule, our dedicated team of scientists is here to provide you with customized services, supported by our extensive network of capabilities and resources. No matter where you are, as an end-to-end pharmaceutical service provider and partner we offer quality, speed and value by combining our technical competencies and cost-effective solutions.

We are backward integrated in pharmaceutical research and development and our focus ranges from the classification and development, to the commercialization of complex liquid (aqueous/non aqueous) and lyophilized injectables in vials and ampoules, with robust capabilities for terminal sterilization as well as aseptically filled injectables.

As a CDMO we are rapidly capturing the highly competitive sterile US market, in collaboration with our partners we have received 21 ANDA approvals, have 18 ANDAs under review and a filing target of 50+ by 2025.

Immacule is focusing on First to File 505(b)(2) submissions, NCEs & complex generics niche products scale-up, exhibit batches & commercial manufacturing support services to its global clients.

Development to Commercial Manufacturing

Sourcing

Sourcing of API including audit & vendor qualification

Formulation Development

- Lab scale development trials.
- Development using QbD guidelines

Analytical Development

- Method development
- Method Validation
- Stability studies

Sourcing

Sourcing of API including audit & vendor qualification

Formulation Development

- Lab scale development trials.
- Development using QbD guidelines

Analytical Development

- Method development
- Method Validation
- Stability studies

Scale up / Technology Transfer Document

- Preparing TTD
- Scale up from lab to scale up / production facility

Scale up / Technology Transfer Document

- Preparing TTD
- Scale up from lab to scale up / production facility

Manufacturing Services

State of the art manufacturing facility to produce highest quality of sterile injectables to cater regulated market of USA, Europe, Australia, Latin America and others

Offer Technologies

Formulation Technologies
- Aqueous solutions - Emuision solutions
- Lyophilized powder - Suspension

Sterilization Technology
- Aseptic sterilization
- Terminal sterilization

Manufacturing Services

State of the art manufacturing facility to produce highest quality of sterile injectables to cater regulated market of USA, Europe, Australia, Latin America and others

Offer Technologies

Formulation Technologies
- Aqueous solutions - Emuision solutions
- Lyophilized powder - Suspension

Sterilization Technology
- Aseptic sterilization
- Terminal sterilization

Our Vision

To become a globally reputed company and suppliers of innovative and high-quality sterile drug
products.

Our Mission

To develop, register and commercialize the maximum generic sterile drug products across all regulated and emerging markets in the world.

Our Vision

To become a globally reputed company and suppliers of innovative and high-quality sterile drug
products.

Our Mission

To develop, register and commercialize the maximum generic sterile drug products across all regulated and emerging markets in the world.

Our Promoters and Group Companies

ACME FORMULATION

Solid Dosage Facility
(General and Hormonal Block)

ACME GENERICS

Solid Dosage Facility
(General Tablets/Capsules and Levothyroxine Tablets)

VERITAS RESEARCH

Contract Research Organization