Both North American DOW PuraGuard PG USP/EP manufacturing facilities have passed the GMP audit and have received certification to excipient
GMPs from IPEA," says Irwin Silverstein, Ph.
As a result, Sheffield should be able to deliver greater value (and business-building results) for customers in the global pharmaceutical market, through innovative excipient
and cell nutrition products and services.
Albumin, as an excipient
, finds wide applications in drug development, vaccine manufacture, drug delivery, and media component in vaccine production, which collectively drives the albumin market.
DKSH s Business Unit Performance Materials, a leading specialty chemicals distributor, has been appointed exclusive Market Expansion Services partner for DFE Pharma s Pharmacel MCC excipient
for France, Switzerland, UK, Ireland, Denmark, Finland, Norway and Sweden.
designed for sustained release matrix tablets - Fully synthetic for batch-to-batch and performance consistency - Suitable for direct compression processes for fast and cost-efficient development and production
New analysis from Frost & Sullivan, Analysis of the Global Human Albumin Market and Product Pipeline, finds that the non-therapeutic use of human albumin as an excipient
has generated plenty of interest from the industry and will create a potential customer base comprising academics, research institutes, and pharmaceutical and biopharmaceutical companies.
Jungbunzlauer has developed TCC TB (tricalcium citrate tetrahydrate), which was designed to function as an excipient
In this study, DMA was cured into a silicone matrix at 5%, 10% and 15% concentrations (m/m) along with varying concentrations of excipient
A (0-20%) or excipient
B (0-12%), The silicone sample was placed in a simulated physiological environment and HPLC analysis was conducted daily on the eluent, allowing quantification of drug release into the physiological solution on a daily basis over 14 days.
Product versatility will be a key factor impacting product mix in excipient
demand going forward, especially as specialty excipient
blends play an increasingly important role in pharmaceutical formulation.
The authors report that labeling information for 6 RX drug products included di-n-butyl phthalate (DBF) as an excipient
and 45 labels specified diethyl phthalate (DEP).
1) In his statement, Carter notes: "IPEC'S proposal would mandate that individuals or companies not be allowed to import into the US a drug or excipient
used in the manufacture of a drug if the product or ingredient was manufactured or produced outside the US by an entity which has not been certified by FDA or an FDA-recognized third-party auditor.
For a new excipient
to be accepted by regulatory authorities, it must undergo the required demonstration studies on chronic and acute toxicity, pharmacokinetics, toxicology and reproductive effects.