product

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product

in PRODUCT LIABILITY, any goods or electricity including any goods comprised in another product whether by virtue of being a component part or raw material or otherwise. ‘Goods’ is defined as including substances, growing crops and things comprised in land by virtue of being attached to it, and any ship, aircraft or vehicle.
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The agency has called on concerned establishment not to distribute the said drug products "until these have already been covered by the appropriate authorization."
FDA warns public anew against six unregistered drug products
However, as Brazilian drug producers are still responsible for 74% of all refused processes and no Brazilian drug product was approved to American or European market on 2015, it can be concluded that they are still not able to follow Brazilian regulation or foreign ones [12, 27].
Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)
The process of integrating these 23 US generic drug products is well underway with the successful manufacture of engineering batches of 1mg and 8mg Doxazosin Mesylate tablets in IDT's Boronia manufacturing facility.
FDA CONFIRMS CHANGE OF OWNERSHIP OF GENERIC DRUGS
Pairing the fill-finish equipment and parenteral packaging components is critical to ensure drug product manufacturing runs efficiently.
Elastomeric closures in parenteral drug packaging: steam vs. gamma sterilization
Critical quality attributes (CQAs), determined with the patient in mind, have been built into the development process to help ensure quality, safety and efficacy throughout a drug product's lifecycle.
West expands NovaPure line
For example, leachables and extractables play an important role when looking at primary packaging material, storage and manufacturing of drug substances and drug products. During manufacturing, the product or its precursors, as well as excipients get into direct contact with different materials; for example glassware, rubber and plastics.
The new health believes in having skin in the game: genotoxic impurities, leachables and extractables the tip of the iceberg? Genotoxic impurities, in particular, are at the focus of attention of the regulatory authorities. Low limits of detection in the trace range presuppose the existence of special analytical techniques for detecting these substances
"At Global Pharmatech, we are always striving for innovation in our drug products whether that is in drug manufacturing or research and development.
Global Pharmatech obtains patent purification methodologies of echinocystic acid
Lonza has entered an agreement to purchase a sterile drug product fill and finish facility from Novartis.
Lonza to Acquire Novartis' Sterile Fill/Finish Facility
"To check if a drug product has been registered with FDA, use the embedded Search feature of the FDA website accessible at www.fda.gov.ph," the agency said.
FDA warns public against six unregistered drug products
SHANGHAI, March 27, 2019 -- STA Pharmaceutical Co., Ltd., (WuXi STA)--a subsidiary of WuXi AppTec--announces that its new drug product manufacturing facility in Shanghai Pilot Free Trade Zone has passed its first GMP inspection by the European Medical Products Agency (MPA).
WuXi PharmaTech (NYSE: WX) - WuXi STA's New Drug Product Manufacturing Facility Passes First European MPA GMP Inspection -- 27/3/2019
In addition, the Company reports that it has completed production of the drug product for the ensuing GLP Safety/Toxicology studies of its lead drug candidate in the HerpeCide program.
FDA responds to NanoViricides' request for pre-IND meeting

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