Welcome to
Astral SteriTech

Leading International Contract Manufacturing and Development Organisation.

Integrated CDMO
for
Strategic Relationship

Post-discovery to commercialization cycle - we do it all under one roof.

State-of-the-art
manufacturing capabilities

Innovation with Quality: Collaborate to Create.

About Us



Core competence of more than three decades as a global CDMO

Globally recognized facility for sterile antibiotic injectable formulations with prestigious regulatory accreditations including WHO-India, USFDA, PIC/S, HPFBI Canada and ANVISA Brazil, with the expertise to serve as a CDMO for Cephalosporin and Semi-Synthetic Penicillin range of powder injectable drug products.

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The Astral Advantage


Quality Control and Product Development Facilities.









Reliable, Quality Oriented & Efficient performance for premier business partnership


Financial Discipline & Reputation to ensure vendor support and supply chain efficiency


One roof service for product development to commercialization to post launch activites


Non-Conflicting Business Plans

Core Team brings a combined experience of ~100 years in the pharmaceutical industry


Consistence compliance track record and cGMP enhancement


Leveraging economies of scale for cost effective operations


Integrated Supply Chain Management Capabilities

Pillars of Strength for Strategic Collaboration


Manufacturing

Extensive and comprehensive experience for manufacturing products with Aseptic Processing Techniques with cGMP compliance offers distinct advantage as support manufacturer.

Quality

Quality Management Systems (QMS) have been progressively upgraded to build in robustness to control processes and data integrity, in the form of module wise installation of the Electronic Data Systems for QMS, Quality Control Lab, Batch Records and Regulatory Submissions.

F&D and Regulatory

Supplementing the manufacturing infrastructure compliant to regulatory accreditations, the in-house capacities and instrumentation infrastructure have been established to support new product formulation developments and new product pipeline for regulatory filings.

Alliances

Seamless and progressive relationships running over multiple decades as a reliable CDMO with reputed national and overseas customers and vendors.

State-Of-Art Infrastructure.
Best-In-Class Processes.


Core manufacturing lines and release testing facilities are equipped with state-of-art technologies from leading pharmaceutical equipment manufacturers to ensure quality and the highest efficiency for all the process stages.


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CORE EXPERTISE


services-1

With a proven expertise, a strong track record and tried-and-true processes, Astral SteriTech offers clinical and commercial Fill & Finish services for antibiotic powder injectables, from formulation to packaging.

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Our integrated approach to quality through our one Quality System and strategic quality plan, together with our culture of continuous improvement ensures compliance with the ever changing regulatory requirements and expectations from our customers.

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services-3

Our regulatory team, provides expert clinical & regulatory support through all phases of drug development and product life cycle. We have extensive experience with compiling, filing and maintaining product registrations for various regulated and semi-regulated markets.

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Formulation development and analytical development conducted as per global regulatory guidelines through in-house quality controlled designs using Quality by Design & Design of Experiment concept.


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