Patient Centricity

API Development

We offer comprehensive support for custom API development, covering Route Scouting, Pre-GMP Kilo Lab, Process Development, and Analytical Development, with expertise and flexibility.

  • The team excels in custom development, possessing the skills and knowledge required to promptly fulfil your small molecule API development requirements while maintaining the highest quality standards.
  • With access to essential resources, expertise, and flexibility, our team offers comprehensive support across various custom API development services, ranging from Route Scouting to pre-GMP Kilo Lab, Process Development, and Analytical Development.
  • Through our fully integrated service, we have the capability to concurrently develop your drug substance, streamlining the overall development process and reducing your time-to-market
  • Our specialized capabilities encompass Peptide API, High Potency API, Hormonal API, and Intermediates.

API Services

Featured Services

Route Scouting

Defining the optimal synthetic route for your molecule is crucial for a consistent and sustainable supply chain throughout your product’s lifecycle.

At Piramal, we specialize in identifying and selecting optimal routes for NCEs and Generic APIs, our route scouting process systematically evaluates various factors to determine the most advantageous pathway. We prioritize considerations such as

  • IP Compliance
  • Cost-Effectiveness
  • Safety
  • Commercial Viability
  • Environmental Friendliness.
  • Chemical Feasibility
  • Efficiency
  • Chemo-Selectivity and Regioselectivity

Process and Analytical Development

For almost thirty years, we’ve specialized in offering pharmaceutical intermediate and API process and analytical development services. Our global presence, with strategic R&D and manufacturing facilities across the US, Canada, and India, offers clients a unique advantage in rapid drug development, proximity to markets, as well as flexible solutions.

We have a talent pool of process chemists and engineers, supported by an infrastructure of fume-hoods, kilo labs, and state-of-the-art analytical instrumentation, along with GMP as well as pre-GMP production areas.
 

Key Capabilities Include

  • Process Development Services
  • Analytical Services
  • Additional Services include Managing impurities, reference standards, toxicity study sample preparation, critical parameter assessment, and regulatory guidance across drug development phases.

Pre-GMP Scale-Up

Our pre-GMP development services offer increased flexibility and speed. With a state-of-the-art facility, we focus on lab-scale experiments. Having both pre-GMP and GMP facilities integrated enables us to seamlessly transition to GMP phases of development for early-stage projects.

Through thorough integration of technologies across our pre-GMP and GMP facilities, we streamline pre-GMP operations and facilitate swift transitions to GMP manufacturing. Ultimately, our seamless process accelerates your project timeline to clinical stages and mitigates risks associated with clinical manufacturing activities.

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Shanghai, China - Sourcing Office

Associate Company of Piramal Pharma Ltd.

Why Collaborate With Piramal?

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