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.