In pharmaceutical R&D, wet granulation is a fundamental process, especially for oral solid dosage forms where flow, compressibility, or uniformity challenges exist. One of the most critical early decisions during formulation development is the choice of granulating solventâeither aqueous or alcoholicâas this directly impacts product stability, impurity levels, granule integrity, and manufacturing scalability. Below is…
Every successful generic drug starts with one essential step â understanding the innovator. Innovator Product Testing is where science meets strategy. Before formulation begins, this stage provides a complete technical blueprint of the reference product. Here’s what it entails: 1. Physical Testing â More Than Just Dimensions We analyze the innovator tablet for: These parameters…
In generic drug development, the materials you source dictate everything downstreamâfrom formulation consistency and regulatory approval to long-term commercial viability. âYour sourcing strategy is not just a procurement exerciseâit’s a regulatory foundation.â Hereâs 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…
In generic drug development, every excipient decision mattersânot just for performance, but for regulatory approval. One of the most underrated tools we have is the FDA Inactive Ingredient Database (IID). The IID isnât just a list. Itâs a strategic database that gives you regulatory confidence while selecting excipients. It contains excipients that are already approved…
In pharmaceutical development, what you know before you start determines how farâand how fastâyou go. The Handbook of Pharmaceutical Generic Development underscores the literature search as the first strategic pillar of generic drug development. Itâs not just academicâitâs operational intelligence. Hereâs what a high-quality literature search accomplishes: Establishes the Regulatory Landscape Knowing the regulatory path…
In pharmaceutical development, understanding your Critical Quality Attributes (CQAs) is not just regulatory jargon â itâs the foundation of Quality by Design (QbD). According to ICH Q8(R2), a CQA is any physical, chemical, biological, or microbiological characteristic that must be controlled within an appropriate range to ensure the desired product quality. These attributes have a…
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