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LGM Pharma

Tailored API sourcing and CDMO services for the full drug product lifecycle

LGM Pharma offers full-service CDMO support from concept through commercialization, plus API sourcing. It provides analytical method development and stability testing for APIs and drug products, with regulatory strategy support for 505(b)(2) and ANDA filings.

Modalities

Development & manufacturing

Structured CDMO capabilities from verified public sources.

Development (D)

Regulatory clearances

Services

About this organization

Overview

LGM Pharma describes itself as a provider of tailored API and CDMO services for the full drug product lifecycle.

Services

  • CDMO services: Full-service CDMO support intended to take a product from concept through commercialization, across dosage forms.
  • API sourcing: Relationships with manufacturers worldwide, presented as a way to reduce supply chain risk and improve access to high-quality APIs.
  • API products: Securing, importing, and delivering niche or complex active pharmaceutical ingredients.
  • Analytical services: Analytical method development and stability testing for APIs and drug products.

Regulatory approach

The site states that it provides a tailored regulatory strategy supported by in-house experts working with R&D. It references 505(b)(2) projects, ANDAs, controlled substances, and HPAPIs as areas of experience, with a focus on FDA-approved cGMP manufacturing.

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