Services

pharmaceutical manufacturing white tablets

MANUFACTURING

A FORMULA FOR SUCCESS

M.E. Pharmaceuticals is a leader in contract manufacturing and pharmaceutical development thanks not only to our experience and commitment to quality but also to our innovative process that keeps everything in motion. It’s a process that ensures superior over-the-counter drugs, dietary supplements, and solid-dose Rx pharmaceuticals—no matter the size, scale, or scope of the product.manufacturing includes various drug dosage forms:

  • Immediate and controlled release tablets and capsules
  • Coated and uncoated tablets
  • Chewable and effervescent tablets
  • Granules
  • Pellets

Our state-of-the-art facility is operated by industry experts and our investment in innovative technologies guarantees quality, consistency, and on-time delivery for every product we manufacture.

pharmaceutical manufacturing blister packets

M.E. Pharmaceuticals packages various drug dosage forms using several methods including:

  • Blister
  • Bottle
  • Tamper-evident, induction-sealed Neck and Body Banding
  • Folding Carton
  • Pouch

INNOVATIONS IN THE LAB

Our analytical chemists develop and validate laboratory methodologies, monitor ongoing stability, and support the formulation and manufacturing process that accelerates commercialization and elevates pharmaceutical development to a new level.

  • Method development and validation
  • Cleaning residuals development and validation
  • Dissolution and drug release profiling
  • Forced degradation studies
  • Stability monitoring to ICH guidelines

pharmaceutical manufacturing white tablets

REGULATORY

EXPERTS IN MEETING AND EXCEEDING REGULATORY REQUIREMENTS

The regulatory process is complicated. Our decades of experience will help you navigate the forever changing regulatory landscape to ensure a successful product launch and total product life cycle. Our team of experts are trained and highly knowledgeable about regulatory requirements in worldwide markets. They work closely with our customers around the globe to prepare both U.S. FDA and international dossiers. Our team monitors global regulations to ensure our strict compliance with:

  • Abbreviated New Drug Applications (ANDAs)
  • New Drug Applications (NDAs) and and 505(b)(2) submission
  • Premarket Approvals (PMAs) for novel combination products
  • Regulatory Review on OTC & Rx products for FDA manufacturing approval
  • Change control and support of post-approval commitments
  • Post-approval stability testing and monitoring of product quality