Elite is an End-to-End Pharmaceutical Company
With decades of experience in research & development, manufacturing, clinical, and regulatory affairs with a proven track record of over 8 patents filed, 9 approved generics and 4 IND/NDA’s
InjECTABLE pLATFORM
Our focus is device systems to create patient-friendly products.
Common route of administration are subcutaneous, intramuscular, Intradermal and intravenous.
Our expert team can formula injectable with release ranging from immediate to weeks to months. Here at Elite, we also utilized microsphere technology for prolong release.
We do:
Sterile liquids
Sterile lyophilized parenteral
Suspensions
Microspheres
Nano particle
and more
We pack in:
Ampoules
Pre-filled syringes,
Cartridges
Vials
and more
Our team has extensive experience with:
Formulation and analytical development
Stability program
Scale-up, registration and validation
Commercialization
Life cycle management
Oral Dosage Forms
Here at Elite, we have extensive experience in solid oral products with a proven track in 505 (b)2 and generic.
Our experience with capsules, and tablets ranges from;
Immediate release
Sustained release
Extended release
Controlled release
Delayed release
Enteric chewable
Orally-disintegrating
Sublingual
Buccal
Lozenge.
Our technology and equipment platform at a glance;
Extrusion and Spheronization
Laser drilling
Tablet printing
Tableting (single, bi-layer and tri-layer)
Encapsulation (powder, pellets combo of pellets and powder, mini tablets, combo of mini tablets with powder and or pellets)
Fluid Bed (wurster, granulation and drying),
Blender
Pan coating
Roller compactor
High shear granulator
Multifunctional hot-melt and spray granulator
Spray drying
Hot-Melt extrusion and Mixing granulator
Nano milling (Wet and Jet milling).
ANALYTICAL
With our expertise and advanced technologies our analytical team are specialized in method development, and optimization, method validation, forced degradation and Method Transfer and stability requirements.
We performed routine test on microbiological testing, API, excipients, packaging components release testing, Intermediate product release testing, Finished product release testing according to USP and ChP.
Here is a glance of our analytical platform;
HPLC-PDA, UV and RI detectors, GC with Headspace Autosampler, FT-IR, UV-Vis Spectrometer, Dissolution Apparatus App I & II with autosampler, Dissolution apparatus III with autosampler (Bio-Dis), Malvern Particle Size analyzer, Powder X-ray Diffraction, Karl Fischer Titrator, Potentiometric Titrator, Total Organic Carbon analyzer (TOC), Melting point apparatus, Rotational Viscometer, Automatic Kjeldahl nitrogen analyzer, Constant Temp and Humidity Chamber, Stability Chamber, and Photostability Chamber.