Pharmaceutical Technology ePT Weekly
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PharmTech
December 26, 2019
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In this issue:

Glenmark Pharmaceuticals Recalls Ranitidine Tablets

Charles River Laboratories to Acquire HemaCare in $380-Million Deal

PharmaMar Files for Accelerated NDA for Small Cell Lung Cancer Drug



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Top Stories

Riverside Acquires Pharma and Food Ingredients Biz from Ferrer

The divestment of the pharma and food ingredients business is in line with Ferrer’s new strategy to focus on the core business of branded pharmaceuticals.
/ read more /


Roche Completes $4.3 Billion Acquisition of Spark Therapeutics After FTC Investigation

The deal was approved by the Federal Trade Commission following a 10-month investigation.
/ read more /

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Industry News

EMA Launches Inspection Pilot Program

The European Medicines Agency and its European partners have launched a pilot program for cooperation in the inspection of facilities that manufacture sterile drug products.
/ read more /


Glenmark Pharmaceuticals Recalls Ranitidine Tablets

Glenmark Pharmaceuticals is recalling unexpired lots of Ranitidine Tablets due to potential presence of N-nitrosodimethylamine (NDMA).
/ read more /


More Industry News
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Supplier News

Colorcon Renovates North America Campus

By consolidating legacy buildings, Colorcon enhances environmental and production efficiencies at West Point, PA facility.
/ read more /


Charles River Laboratories to Acquire HemaCare in $380-Million Deal

The acquisition expands Charles River’s scientific capabilities in cell therapy development.
/ read more /


More Supplier News

Bio/Pharma News

Sartorius Establishes Scientific Advisory Board

The new scientific advisory board will oversee innovation projects, identify and develop key new technologies, and be responsible for forming high-caliber alliances with innovative start-ups.
/ read more /


PharmaMar Files for Accelerated NDA for Small Cell Lung Cancer Drug

The company has filed an NDA for lurbinectedin and is seeking accelerated approval for treatment of relapsed small cell lung cancer.
/ read more /


More Bio/Pharma News

Regulatory News

Pennsylvania Facility Receives Warning Letter

FDA sent a warning letter to Dercher Enterprises, Inc., DBA Gordon Laboratories, for CGMP violations and adulterated drug products.
/ read more /


FDA Publishes Guidance on NDC Codes

The guidance describes procedures for obtaining an additional National Drug Code for prescription drugs imported into the United States.
/ read more /


More Regulatory News

Featured Topics

SUPPLY CHAIN

Mitigating Risk to Secure the Drug Supply Chain

Communications and planning are crucial to recovering from supply, operations, and facility disruptions.
/ read more /


REGULATORY WATCH

Quality Issues Offset Biomedical Advances

Problems in assuring reliable drug quality and supply dampens progress in bringing lifesaving therapies to market.
/ read more /

 
API SYNTHESIS AND MANUFACTURING

Managing Excipient Interactions

The key is to ensure that excipients only interact with APIs via desired mechanisms.
/ read more /


DRUG DEVELOPMENT

Tackling Solubility in Drug Development

Spray drying is a versatile and rapid technique that can provide companies with a suitable and scalable option to improve the solubility and bioavailability of drug products.
/ read more /


ON DEMAND WEBCASTS


A Roadmap for Early Development to Commercial Manufacturing
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Events

SMi Group’s 12th Annual Conference and Exhibition: Pre-Filled Syringes and Injectable Drug Devices 2020

January 15–16, 2020

SMi’s 9th Annual Pharmaceutical Microbiology Conference

January 20–21, 2020

Pharmapack

February 5–6, 2020


more events

eBOOKS

Biologics and Sterile Drug Manufacturing 2019

The editors explore novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.


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