API Development

We offer comprehensive support for custom API drug development services, 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 ly 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

BROCHURE

Featured Services

Expert API Route Scouting Services

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 API route scouting, identifying and selecting the most efficient routes for NCEs and Generic APIs. Our route scouting process systematically evaluates various factors to determine the most advantageous pathway, ensuring optimal outcomes. We prioritize key considerations such as:

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

Process Development Services

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, and flexible solutions.

We have a skilled 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 both GMP and 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.

Seamless GMP Peptide Manufacturing

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 the 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, including GMP peptide manufacturing.