Niche among the semi-solid category of pharmaceutical dosage forms, suppositories require expert knowledge and skill to formulate, develop, and manufacture. Because the active pharmaceutical ingredient (API) penetrates mucosal membranes of the vagina or rectum, suppositories must be gentle and non-irritating, stable until inserted, and dissolve to deliver therapeutic relief.
LGM Pharma has invested in the personnel, technologies, and equipment to formulate, manufacture, and package, under GMP standards, more than 35 million suppository doses annually.
Suppository formulation, development, and manufacturing is LGM Pharma’s forte:
We formulate, develop, test, manufacture, and package suppositories at our 54,000-square-foot facility in Rosenberg, Texas. This state-of-the-art facility is fully licensed and accredited for GMP manufacturing. FDA inspections and annual customer audits reveal no current issues or observations.
Long before the FDA established Quality by Design practices, LGM Pharma bred quality into the development of its manufacturing and production processes. Whether we formulate your suppository dosage form or transfer it in, we develop, validate, and enforce strict manufacturing protocols. We ensure Critical Quality Attributes are maintained for a reproducibly safe, efficacious, and stable finished product.
From securing high-quality active pharmaceutical ingredients (API) to manufacturing finished drug product, LGM Pharma can bring your suppository formulation to market. In-house analytical testing services are also part of your CDMO engagement.
End-to-end capability in our U.S.-based facilities is particularly valuable if you’re looking to reshore your drug manufacturing or to reformulate, for example, under the 505(b)(2) pathway.