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Drug Product

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...

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The Food and Drug Administration (FDA) issued a draft guidance listing the enforcement of product...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...