U.S. 503B Compounding Pharmacies Market
These are specialized types of drug manufacturing organizations that serve a critical role in the patient care, as stated by the United States Pharmacopoeia (USP), compounding provides access to medication for patients who may not be able to use commercially available formulations due to dosing requirements, allergies, or rare diseases. The 503B compounding pharmacies are required to be registered with the U.S. FDA and maintain full compliance with the current good manufacturing practices (cGMP).
The cGMP guidelines compounding pharmacies needs to follow are 503B compounding pharmacies are must validate every process according to CGMP.
503B facilities must produce multiple batches and submit them for testing and stability before a new product can be brought to market.
503B products and testing methods must be validated according to US pharmacopeia (USP). Similarly, all suppliers and vendors providing raw materials must be evaluated. Moreover, onsite inspection must be performed by quality personnel.
Market Dynamics
The increasing launches of 503B compounding pharmacies in the U.S and increasing adoption of inorganic growth strategies such as mergers, acquisitions, partnerships, and collaborations by key players operating in the market are the major factors that are expected to drive growth of the U.S. 503B compounding pharmacies market over the forecast period.
For instance, in January 2022, Hikma Pharmaceuticals PLC, the multinational pharmaceutical company, announced the launch of Hikma 503B, a new outsourced sterile compounding business focused on providing high quality, ready to administer injectable medications that are customized to the specific need of patients in the U.S.
Key features of the study:
Detailed Segmentation:
“*” marked represents similar segmentation in other categories in the respective section.
Table of Contents
*Browse 6 market data tables and 32 figures on "U.S. 503B Compounding Pharmacies Market” - forecast to 2030.
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