API manufacturing companies explore India’s journey towards leadership, challenges, emerging trends, and strategic insights for navigating path effectively.
India’s pharmaceutical sector stands on the brink of a profound transformation, positioning itself as a global leader in pharmacy. As we step into 2018, the API industry braces for significant changes. For the past two decades, China has held sway as the primary source of APIs and intermediates worldwide. However, indications suggest a departure from this norm. The costs of APIs and intermediates are on the rise, signaling a shift in dynamics. Moreover, doubts loom over the reliability of the supply chain, with the Chinese government tightening regulations on environmentally non-compliant factories.
Despite the industry’s heavy reliance on cost-effective sourcing solutions, the specter of supply chain uncertainty demands proactive measures from companies. Disruptions in the supply chain could translate to a loss of market share, presenting a formidable challenge for companies to recover their standing. Additionally, while India accounts for over 50 percent of drug master files (DMFs) submitted to the US Food and Drug Administration (USFDA), the bulk of APIs and key starting materials still originate from China.
Concerns surrounding Good Manufacturing Practice (GMP) compliance persist in both India and China. Although instances of non-compliance in API manufacturing were relatively rare in 2017, anticipation mounts for the USFDA to address staffing issues and ramp up inspections across Asia.
Amidst an evolving regulatory landscape, characterized by the heightened emphasis of ICH Q11 on key starting material selection, the imperative for selecting new API suppliers that meet global regulatory standards becomes paramount.
Regulatory inspections increasingly emphasize the capacity to handle deviations and out-of-specification (OOS) issues. Therefore, it is crucial to ensure that projects are supported by organizations capable of addressing investigator concerns during upcoming inspections.
With over three decades of industry experience, CRMO has honed expertise in project outsourcing. We are thrilled to share our Project Outsourcing Guide, aimed at assisting other companies in navigating their outsourcing endeavors.
Selecting the right strategic partner and maintaining effective oversight are essential to safeguard project costs, timelines, and quality standards—a critical consideration for organizations seeking CMOs (contract manufacturing organizations).
At PharmaLinkage, we offer comprehensive support for vendor QA functions, ensuring the requisite expertise to maintain consistent compliance and address regulatory inquiries promptly.
Furthermore, our risk assessment services ensure meticulous selection of both GMP and non-GMP starting materials, facilitating accurate forecasting and monitoring to ensure timely product delivery. Clear and open communication channels are vital for successful product transfers or development.
We prioritize confidentiality, facilitating seamless technology transfers. Over the years, we have earned a reputation as a trusted outsourcing partner in the industry.
API Manufacturing Companies
API Manufacturing Companies
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