Posts about
Drug Product
Alcami Announces Parenteral Operations Leadership Appointments
DURHAM, N.C. – October 12, 2021 - Alcami, a leading United States-based contract development and...
Alcami Expands Parenteral Operations with Additional Investment
CHARLESTON, S.C. – September 29, 2021 - Alcami, a leading United States-based contract development...
EDITORIAL: Combination Products and their Regulatory Pathway
Combination products are becoming increasingly important to pharmaceutical CDMOs like Alcami, said...
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...
Blog: Regulatory Requirements for Early Phase Drug Product Development
Supporting a compound from discovery to clinical phases and potentially commercial phases requires...
Quota, Import, and Export Processes for DEA Controlled Substances
Controlled drug substances are scheduled based on medical use in treatment, potential for abuse,...
Alcami Helps Secure FDA Approval for MDGH
Durham, NC (USA) – October 25, 2018 – Alcami Corporation, a leading provider of fully-integrated...
Blog: Formulating for Orphan Indication Drug Products
According to the US Orphan Drug Act of 1983, a rare disease is defined as a condition that affects...
The Role of FTE (FULL TIME EQUIVALENT) Programs
An FTE agreement is considered a comprehensive analytical service that allows pharmaceutical and...
Alcami’s Extended Workbench Supports Commercial Supply of Flexion Therapeutics’s ZILRETTA® (triamcinolone acetonide extended-release injectable suspension)
Durham, NC (USA) – June 13, 2018 – Alcami Corporation, a leading provider of fully-integrated...
Case Study: Implementing Serialization
The Food and Drug Administration (FDA) issued a draft guidance listing the enforcement of product...
Case Study: Challenges and Solutions to Formulating an Orphan Drug
According to the Food and Drug Administration and the Orphan Drug Designation program, orphan...
Video: Charleston Regional Development Alliance Features Alcami
Alcami's Charleston, South Carolina site is featured in a video produced by the Charleston Regional...