Drug Substance

An active ingredient intended to furnish pharmacologic activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body; it does not include intermediates used in the synthesis of such an ingredient
References in periodicals archive ?
There was one knife more than 3in confiscated, along with three less than three inches, five tools, three cameras, one recording device, ten sharp items and one drug substance.
M2 PHARMA-October 12, 2017-Samsung BioLogics awarded first US FDA approval at the world's largest biologics drug substance plant
M2 EQUITYBITES-May 18, 2017-Kemwell Biopharma supplies biologics drug substance to US customer for Phase 1 clinical trials
The acquisitions will expand Avecia's analytical capabilities and complement its oligonucleotide drug substance services.
The bulk drug substance for Vaxchora is manufactured at SynCo Bio Partners' Amsterdam facility.
Any change that occurs in a drug substance or product subsequent to its manufacturing, packaging, storage, distribution, or in-use, which drastically affects the quality of drug product in terms of its fitness for use by the patient, is a matter of concern for health regulatory authorities and pharmaceutical industries.
There are also systems designed to first undergo a moisture/liquid uptake process as soon as they enter the gastrointestinal tract and continue to do so until the coating bursts and the drug substance is released.
The company promotes it as a natural product while the lab investigations conducted by the Central Laboratory pointed out that it contains 'tadalfil', a drug substance used on a subscription from the doctor and under medial supervisor.
Drug substance properties must be taken into account when developing the product formulation and manufacturing process.
Key workshop objectives include discussion of the OGD's new review process and filing expectations for type II DMFs (drug master files) for drug substance and an analysis of the office's expectations for regulatory filing and review of stability for drug products.
They cover commercial therapeutic protein drug products, a formulations method to improve the physical stability of macromolecular-based drug products, properties of protein formulations, material and process compatibility testing, compounding and filling to turn a drug substance into a drug product, administration in the clinic, and regulatory guidelines for developing a biotechnology drug product.
Summary: SHARJAH -- The Sharjah Court of First Instance on Wednesday sentenced five persons to one to five years imprisonment for consuming Tramadol tablets, an illegal drug substance.