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Blog: 505(b)(2): What You Need to Know

In recent years 505(b)(2) approvals have experienced double-digit growth. Many companies are...

Roundtable Discussion: Greatest Drug Molecules to Impact Society

Q: What two or three drug molecules do you identify as having had the greatest impact on society?...

Editorial: Reducing Risk with Abuse-Deterrent Formulations

Increasing prevalence of drug misuse and abuse is driving a heightened and more stringent approach...

Alcami Bolsters Leadership Team with Quality & Regulatory Appointments

WILMINGTON, NC – May 21, 2020 – Alcami, a North Carolina-based contract development and...

Alcami Appoints EVP of Drug Product Operations and VP of Laboratory Operations

WILMINGTON, NC – MAY 18, 2020 – Alcami, a North Carolina-based contract development and...

Component Selection Equates to Successful Sterile Fill-Finish Manufacturing

As a contract manufacturer, Alcami provides experience in all aspects of the manufacturing process,...

Blog: Successful Methods for Obtaining Orphan Drug Approval

Signed into law on January 4, 1983, the Orphan Drug Act (ODA) allows for granting special status to...

Alcami Supporting Potential COVID-19 Treatment

WOODCLIFF LAKE, N.J. —April 16, 2020— Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle”), a New...

Challenge Accepted! Problem-Solving Examples for Packaging Dilemmas

Even well-designed product formulations can fail if it is contained in inappropriate packaging. How...

Full-Time Equivalent Programs: Outsourcing Analytical Testing

Alcami’s end-to-end analytical testing platform supports clients’ programs through every stage of a

Benefits of Establishing a Full-Time Equivalent (FTE) Program

A Full-Time Equivalent (FTE) agreement is a comprehensive analytical service that grants...

Alcami Expands Sterile Fill-Finish Capacity with TRIPHARM Acquisition

Transaction Advances Alcami’s Strategic Plan by Adding Scale in Attractive and Growing Parenteral...

CHEMISTRY ANALYST SPOTLIGHT: Katie Shupe

Name: Katie Shupe

Alcami Site: St. Louis, MO

What is your role?

I am a lead chemistry analyst. I...

Alcami Expanding Parenteral Operations in SC

Durham, NC (USA) – December 17, 2019 – Alcami Corporation, a leading provider of fully-integrated...

LYOPHILIZATION SPOTLIGHT: Norman Chieng

Name: Norman Chieng, PhD

Alcami Site: Charleston, SC 

What is your role? I am a senior scientist in...

Blog: The Importance of Secondary Packaging

There are three main types of packaging – primary, secondary, and tertiary – and it is important to...

Alcami Launches New Rapid Sterility Testing Services

Durham, NC (USA) – October 8, 2019 – Alcami Corporation, a leading provider of fully-integrated...

Blog: Regulatory Requirements for Early Phase Drug Product Development

Supporting a compound from discovery to clinical phases and potentially commercial phases requires...

Blog: Top Stability Testing Factors You Should Consider

Stability testing is a fundamental part of the drug development process— upholding the quality of...

The Top 8 Most Asked Questions about Microbial In-Use Studies

According to Dr. John Metcalfe, “pharmaceutical companies go to great lengths to manufacture a drug...

White Paper: Insight into Orphan Drug Formulations and Regulations

The US Orphan Drug Act of 1983 characterizes an orphan disease as a rare medical condition that...