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 2022:

  • 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.
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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