Semi-Solid Dose Form

Trust LGM Pharma to Manufacture the Full Range of Semi-Solids Dosage Forms

Growing opportunities for high-quality semi-solid drug product

Manufacturing the range of semi-solid dosage forms is both science and art. Properly mixing, under precise conditions, the topical creams, ointments, gels, pastes, foams, and oral chewables in the semi-solid category requires knowledge, skill, and the right technology. LGM Pharma possesses that winning combination of expertise, resources, and equipment to produce high-quality semi-solid finished drug product at our 54,000-square-foot manufacturing facility in Rosenberg, Texas. With in-house expertise from API procurement, formulation development and analytical testing to manufacturing and packaging, we offer end-to-end services. This is particularly valuable if you’re looking to reshore with one CDMO or reformulate, for example, under the 505(b)(2) pathway.

Specialists in Semi-Solid Pharmaceutical Products

Trust LGM to manufacture all types of semi-solid dosage forms:

  • Creams, ointments, pastes, gels, chewables
    • Including products having ointment base-to-pH adjustments, preservatives to antioxidants, solvents to mineral salts, and more
  • Generic and innovator
  • Prescription and over-the-counter
  • Flexible batch size
    • Small, medium, or large clinical and commercial batches
    • Typical commercial batch sizes of 1200-6600 kg

LGM also offers unit and bulk pharmaceutical packaging solutions, with track and trace capabilities planned for late 2021:

  • Plastic and glass jars and bottles
  • Metal and plastic tubes
  • Multiple closure systems
  • Labels, barcode labels, and coding
  • Carton, bundle pack, and case pack

Your product can be expertly formulated, manufactured, and packaged for distribution at our GMP facility. This state-of-the-art site is fully licensed and accredited for GMP manufacturing. FDA inspections and annual customer audits reveal no current issues or observations.

Attention to detail means high quality

A focus on details, commitments, and regulatory compliance means your product is manufactured to the highest quality. Establishing a Design Space ensures the drug product exhibits all predefined Critical Quality Attributes in areas such as:

  • Heating or cooling
  • Process forces
  • Process adjustments
  • Equipment speed
  • Process times
  • Bulk hold times

 LGM quality systems and process controls ensure a check on each and every batch produced.

Full-Service Capabilities

From securing high-quality active pharmaceutical ingredients (API) to manufacturing finished drug product, LGM Pharma can bring your semi-solid formulation to market. In-house analytical testing services are also part of your CDMO engagement. End-to-end capabilities in our U.S.-based facilities is particularly valuable if you’re looking to reshore your drug manufacturing or to reformulate under the accelerated 505(b)(2) pathway.

Partner Smart

Unique Outsourcing Models

At LGM Pharma, you’re more than a customer. We’re partners – and successful partnerships have “win-win” outcomes. That’s why we offer standard fee-for-service packages, joint-venture partnerships, and risk/profit-sharing models.

Explore Partnership Models