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Pharmaceutical manufactures with ﬂexible support services and strong technology platforms.
Sofgen offers Integrated
At Sofgen Pharmaceuticals we work
with the efficiency, quality, quality, innovation, and flexibility
to work with your most challenging projects.
With an in-depth knowledge of development services, our experts are driven by science and technology to
solve any formulation challenges
and requirements through all stages.
Some of our R&D Services include
Development of novel patentable formulation.
Fill formulation development:
Solution, suspension, self emulsifying drug delivery systems, lipid-based drug delivery systems and controlled release.
Gel formulation development.
Gel/Fill compatibility study.
Small-scale encapsulation early development and fin formulation selection follo Quality by Design(QBD) cG Clinical Supplies manufacturing and packaging.
Support and value
during all stages
Our Team works closely with our customers to
and develop a regulatory strategy that guarantees the best quality, timely submissions, and faster, positive registration outcomes.
We also count with
experience preparing submissions in eCTD Format, and provide support
during the application phase and beyond, including annual reports and other post approval submissions.
We have proven expertise in
technology transfers, product launches, product development
and manufacturing technologies.
Our success in
developing precise analytical methods and delivering unmatched quality
in routine analytics, gives us experience that is vital to the success of your project Integrated analytical capabilities, mixed with top-of-the-line equipments, and scientific expertise.
Analytical method development, validation, and testing.
Validation of Swab Methods for Cleaning Verification
Batch/lot release testing for APIs, raw materials and formulated drug products.
(to support formulation development, preclinical, clinical and registration activities)
Compendia testing of raw materials.
HPLC (High Performance Liquid Chromatography)
Dissolution (Apparatus I, II, III, IV)
FTIR (Fourier-Transform Infrared Spectroscopy)
TLC (Thin-Layer Chromatography)
Karl Fischer Viscometer Polarimeter Refractometer Density Meter
Extensive experience with
the technical knowledge
to manage every aspect you require. Our team of engineers offer comprehensive services based
on cost, flexibility and customer experience.
Our bottling capabilities include
Receiving - Storage - Distribution
Capabilities and Services
FDA approved Manufacturing and Storage facility.
Quarantine Warehouse containing GMP / Non-GMP Pallet Locations.
Large Released Warehouse containing Material Pallet Locations.
24-hour Alarm Service for site monitoring.
Cold Storage Capability.
Environmental monitoring and recording of temperature and relative humidity.
Advanced Camera Network with DVR.
for various pharmaceutical products,
Inventory Control, Audit, Cycle count, Variance.
Reports with Reconciliations.
Secured Storage Capability for Controlled Substances.
DEA secure storage location in the Quarantine Warehouse.
Segregated cages are in quarantine warehouse for On-Hold and Rejected materials.
Future Warehouse Optimization plans to allow additional pallet locations in Quarantine and Released Warehouses
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get in contact with you
and find the best solution for your needs.
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