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June 25, 2019

Newsletter Sponsor

Cambrex Highly Potent API Development & Manufacturing Services

Cambrex offers clients a truly end-to-end partnership for the research, development and manufacture of small molecule highly potent APIs (HPAPIs) across its global manufacturing network, to support a drug at every stage of its lifecycle. With flexible assets in its facilities across the USA and Europe, Cambrex covers HPAPI containment occupational exposure limits (OEL) from 10 down to <0.1>³.

	Industry News

Premier Pharmacy Labs Issues Recall of all Unexpired Sterile Drug Product Lots

FDA Statement on Effort to Improve Transparency, Predictability for Generic Drug Applicants

Cytovance Biologics Completes Second FDA Pre-Approval Inspection of Oklahoma City Facilities

PPS Invests $10 Million to Expand its High Potency API Capability in Riverview Facility

TEDOR Pharma Selects AssurX Quality Management Software

Tekni-Plex Completes Acquisition of Three Healthcare Packaging Plants

	Featured Articles

The Industry Conundrum: Curbing Rising Drug Prices While Keeping Pharma Firms Profitable Earlier this year the news that big pharma was raising the price of more than 1,000 drugs created outrage nationwide. read more »

Regulatory Update: Premarket Notification 510(k) Class II Devices The Premarket Notification (510(k)) pathway for medical device approval presents challenges for device manufacturers, FDA reviewers, and patients. read more »

	Featured Video

Watch Video: Pyramid Laboratories Facility Tour
PYRAMID Laboratories, Inc. is a CDMO, focused on parenteral drug products, that offers comprehensive pipeline of services to pharmaceutical and biotech companies. read more »

Watch Video: Liza Rivera from Fujifilm Diosynth Biotechnologies discusses Outreach
Watch Video: Liza Rivera from Fujifilm Diosynth Biotechnologies discusses Outreach read more »

	Featured Whitepaper

Considerations for Development of a Lyophilized Biosimilar The patents for a number of parental biologic formulations are destined to expire in the United States between 2016 and 2027. This provides ... read more »

Colonic Delivery Technology Capsugel Dosage Form Solutions offers several technologies combining liquid-fill formulation and capsule coating approaches for targeted delivery to ... read more »

	Events

8th Clinical Trials Inspection Readiness Summit
Philadelphia, PA – 08/14/2019
The 8th Clinical Trials Inspection Readiness Summit is intended to arm attendees with strategies when designing and implementing a culture of ... event details »

QC Micro Summit 2019
Charleston, SC – 09/24/2010
We’ve revamped our QC Micro Summit to expand on our thought leader speaker lineup and scientific program to allow you to keep pace with new industry ... event details »

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