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.
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.
Sourcing of API including audit & vendor qualification
- Lab scale development trials. - Development using QbD guidelines
- Method development - Method Validation - Stability studies
Sourcing of API including audit & vendor qualification
- Lab scale development trials. - Development using QbD guidelines
- Method development - Method Validation - Stability studies
- Preparing TTD - Scale up from lab to scale up / production facility
- Preparing TTD - Scale up from lab to scale up / production facility
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
Formulation Technologies - Aqueous solutions - Emuision solutions - Lyophilized powder - Suspension Sterilization Technology - Aseptic sterilization - Terminal sterilization
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
Formulation Technologies - Aqueous solutions - Emuision solutions - Lyophilized powder - Suspension Sterilization Technology - Aseptic sterilization - Terminal sterilization
To become a globally reputed company and suppliers of innovative and high-quality sterile drug products.
To develop, register and commercialize the maximum generic sterile drug products across all regulated and emerging markets in the world.
To become a globally reputed company and suppliers of innovative and high-quality sterile drug products.
To develop, register and commercialize the maximum generic sterile drug products across all regulated and emerging markets in the world.
Solid Dosage Facility (General Tablets/Capsules and Levothyroxine Tablets)
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Call us
+91 - 172 350 6244
Email us
info@immacule.in
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