Astral SteriTech
Time 2022-08-14 16:53:16Web Name: Astral SteriTech
WebSite: http://www.astralsteritech.com
ID:280972
Keywords:
Astral,SteriTechDescription:
Welcome to
Astral SteriTech
Leading International Contract Manufacturing and Development Organisation.
Learn MoreAstral
SteriTech
A Company of Centrient Pharmaceuticals
Find out moreIntegrated CDMO
for
Strategic Relationship
Post-discovery to commercialization cycle - we do it all under one roof.
Learn MoreState-of-the-art
manufacturing capabilities
Innovation with Quality: Collaborate to Create.
Find out moreAbout 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.
Learn MoreCentrient Pharmaceuticals
Centrient Pharmaceuticals and Astral SteriTech have partnered to bring the global market of customers and patients a more extensive and diverse product portfolio.
Learn MorePillars 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.
CORE EXPERTISE
Aseptic Fill & FInish
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.
Quality
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.
Learn MoreRegulatory
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.
Learn MoreProduct Development
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.
Astral SteriTech - A Company of Centrient Pharmaceuticals
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