Source Change

Formulation

Sourcing of Raw Materials for Formulation Development
ByPharma Lesson May 31, 2025May 31, 2025 Reading Time: 2 minutes

In generic drug development, the materials you source dictate everything downstream—from formulation consistency and regulatory approval to long-term commercial viability. “Your sourcing strategy is not just a procurement exercise—it’s a regulatory foundation.” Here’s what a smart, compliant, and inspection-ready sourcing strategy looks like: 1. Use Only Commercial-Grade Raw Materials Why it matters? Using research-grade or…

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Formulation

Key Considerations for API Source Change in Formulation
ByPharma Lesson March 16, 2025March 16, 2025 Reading Time: 2 minutes

Changing the API source requires evaluating its impact on safety, efficacy, stability, and manufacturability. Below are the key factors to assess: Physicochemical Properties Dissolution & Bioavailability Stability Considerations Regulatory & Compliance Manufacturing & Process Impact In-vivo Considerations Risk Assessment & Final Decision Conclusion API source changes demand scientific, regulatory, and process evaluations to prevent any…

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