stability study was the second main reason for marketing authorization refusal.
We are focused on getting these drug products
back on the market as quickly as possible using established and strong distribution partners."
These patient considerations regarding ease of use and consistent device performance can be influenced by the sterilization method and have an impact on a patient's overall experience with a drug product
Hanns-Christian Mahler, head of drug products
services, Lonza Pharma & Biotech, said, "Launched just three years ago with a core team of experts, Lonza DPS has since expanded in line with customer demand.
The agency identified the unregistered drug products
as ChingChunbao Anti-aging Tablets, Butiao Tablets, Ma Pak Leung Viga-Pro Pill, Bull Head Brand Feng Sai Gu Tong Ling, Yu Ren Tang Rheuma-Herbs Plus, and Tums Peppermint Regular Strength.
In conjunction, WuXi Biologics will enable and support the "Global Dual Sourcing within WuXi Biologics" strategy and manufacture both the drug substance and drug product
, each at two sites across its global commercial supply network in EU, China and US.
2017, twenty-six received all required drug product
tracing information from their trading partners, while 14 were missing these elements, including two that the report said were "unaware of the DSCSA and requirements for drug product
'All establishments and outlets are hereby warned against selling and dispensing of this verified counterfeit drug product
with the above mentioned features,'' the agency said.
For more than 25 years, Quotient Clinical has brought innovation to drug product
development programmes for pharmaceutical and biotechnology customers worldwide through the integration of formulation development, real-time GMP manufacturing and clinical testing activities.
Retail prices for almost three-quarters of the drug manufacturers with at least one specialty drug product
in the study's market basket increased faster than the rate of general inflation (1.5%) in 2013.
Generics is a drug product
that is comparable to a brand/reference listed drug product
in dosage form, strength, quality and performance characteristics, and intended use.