Pharmaceutical Outsourcing Company Focus: A Russell Publishing Publication

COMPANY DESCRIPTION

Fleming Pharmaceuticals, established in 1960, manufactures popular brands such as Ocean® Saline Nasal Spray in its single location manufacturing facility. Uncompromising quality, insistence on the highest standards, unequalled responsiveness to its contract customers and a special relationship with the healthcare community endure today as pillars of Fleming’s heritage. Based in the greater St. Louis area, the privately-held company houses state-of-the-art
pharmaceutical manufacturing and packaging equipment, analytical and microbiological laboratories, research and development, distribution, sales and marketing, and business administration functions. Quality systems have been developed using ICH Q10 “Pharmaceutical Quality System” and FDA Guidance for Industry “Quality Systems Approach to Pharmaceutical cGMP Regulations”
along with CAPA systems to fully address all nonconformances and to drive efficiency and reduce costs. If you desire quality and responsiveness in a contract developer or contract manufacturer then you should consider Fleming.

COMPANY BACKGROUND

Date Founded 1960
# of employees 90

Key Personnel

• Scott Sims, Vice President Business Development

Fleming Pharmaceuticals has developed products for a variety of clinical conditions related to allergies, cough and cold, nutritional deficiencies, and disorders of the skin for not only its own brands but also for other companies. Fleming specializes in the development and manufacture of innovative prescription and over-the-counter (OTC) therapies and is the proud maker of CaloMist®, Magonate®,

SERVICES & CAPABILITIES

Fleming Pharmaceuticals has established a history of providing expertise in formulation development and manufacturing in a wide range of dosage forms for NDAs, ANDAs and OTC products. Dosage form capabilities include nasal sprays, liquids, semi-solids, gels, creams, ointments, topical preparations, tablets and capsules. The company has a proven track record designing and executing CMC studies for regulatory submission. In its FDA approved facility, Fleming follows [21 CFR210/211 regulations]. Fleming Pharmaceuticals offers responsive and efficient formulation and drug delivery research and development services. This unique approach and agility supports customer requirements for small volume, short term
projects as well as large-volume, ongoing projects. Fleming’s responsiveness and service will improve and enhance your supply chain product needs.