Akorn Inc.
Lake Forest, IL www.akorn.com (800) 932 5676
DRUG TYPE: Pharmaceuticals
Manufacturing locations: Decatur, IL, Paonta Sahib, HP (site with available capacity), India, Somerset, NJ Contact: Sumeet Dagar, Ph.D. sumeet.dagar@akorn.com
DRUG LIFE CYCLE STAGES:
Formulated Drug Production – dosage form development, dosage form production, packaging, and logistics
SERVICES OFFERED: Aseptic fill/finish, controlled substances, creams & ointments, cytotoxic & high-potency compounds, generics, injectables, liquids, lyophilized products, ophthalmics, oral powders, OTC, parenterals (small volume), peptides, powders (sterile), solutions & suspensions, and sterile.
DRUG TYPE: Pharmaceuticals DRUG LIFE CYCLE STAGES: Research & Development – clinical (phase 2 and phase 3)
Formulated Drug Production – dosage form development, dosage form production, and packaging
SERVICES OFFERED: Aseptic fill/finish, capsules, controlled substances, high-potency compounds, injectables, parenterals (small volume), powders (sterile), solid dose, sterile, and sustained release.
Alkermes Westmeath, Ireland www.alkermes.com/contract 353 906495000
Manufacturing locations: Ireland and United States Contact: Fidelma Callanan fidelma.callanan@alkermes.com
"Alkermes Contract Pharma Services are honoured to be recognized by our peers through this CMO Leadership Award. We have a proud history of quality with multiple regulatory authorities including the EMA and U.S. FDA, across our global sites. We strive to have the highest regulatory and quality standards, exemplified by our culture of 'Building Quality' in every- thing we do for our partners." — James Botkin, SVP of operations
Almac Group
Craigavon, Northern Ireland www.almacgroup.com 44(0)28 38332200
DRUG TYPE: Pharmaceuticals
Manufacturing locations: Craigavon, Northern Ireland, Pennsylvania, U.S.A., and North Carolina, U.S.A. Contact: Kerry Lyle kerry.lyle@almacgroup.com
DRUG LIFE CYCLE STAGES:
Research & Development – discovery, pre-clinical, & clinical (phase 1, phase 2, & phase 3) Drug Substance Production – primary process development and drug substance production
Formulated Drug Production – dosage form development, dosage form production, packaging, and logistics
SERVICES OFFERED: Capsules, controlled substances, cytotoxic & high-potency compounds, generics, non-sterile, peptides, powders (non-sterile), proteins, solid dose, and sustained release.
SERVICES OFFERED: Generics and peptides. DRUG TYPE: Biopharmaceuticals DRUG LIFE CYCLE STAGES:
Research & Development – discovery, pre-clinical, & clinical (phase 1, phase 2, & phase 3) Drug Substance Production – primary process development and drug substance production
AmbioPharm,Inc. North Augusta, SC www.ambiopharm.com (415) 921-3593
Manufacturing locations: North Augusta, SC and Shanghai, PRC Contact: Jim Hampton sales@ambiopharm.com
"It is extremely encouraging that our customers regard Almac so highly in quality, innovation, productivity, regulatory, and reliability which is how we strive to be perceived through our core values and our overall aim of "partnering to advance human health". Working with all the leaders in the pharmaceutical and biotech sectors, our aim is to establish long-term partnerships and the fact that over 95% of our business is repeat is genuine evidence of our success." — Alan Armstrong, CEO
"AmbioPharm, Inc. (APi) is a full-service peptide manufacturing company headquartered at our cGMP peptide manufacturing facility in North Augusta, SC. In our cGMP manufacturing facility in Shanghai, China, we manufacture peptides on very large scales, provide pilot manufacturing and process development, and manufacture raw materials, building blocks, and custom peptides."
— Chris Bai, president and CEO The CMO Leadership Awards 2012 35
DRUG LIFE CYCLE STAGES