Continually Harnessing Our Scientific Excellence to Deliver World-Class API and Intermediate Solutions.
Aster Biotech Limited, headquartered in London, is a specialist outsourcing solutions partner focused on sourcing and managing high-quality APIs and advanced intermediates from India. Built on deep scientific knowledge and a commitment to compliance, we serve innovators, specialty pharma companies, generic manufacturers, and emerging biotech enterprises seeking reliable, scalable, and cost-efficient manufacturing.
We bridge global demand with India’s world-class chemistry capabilities—ensuring supply chain integrity, regulatory alignment, and long-term operational continuity.
Our oversight model prioritizes lifecycle consistency rather than transactional supply. This means continuous monitoring of compliance, transparent documentation flow, escalation mechanisms, CAPA closure visibility and proactive regulatory intelligence updates.
We support innovators, specialty pharma, generics, and emerging biotech companies that demand compliant, reliable and scalable manufacturing.
We operate at the intersection of science, quality, and supply chain – translating complex manufacturing needs into secure, well-managed partnerships.
Through structured partner qualification, deep technical due diligence, transparent data sharing, and ongoing regulatory oversight, we eliminate the friction traditionally associated with offshore sourcing and manufacturing.
As markets demand greater assurance around quality systems, data integrity, and audit readiness, Aster strives to represent a new standard of trust in Indian pharmaceutical manufacturing. By continuously strengthening our partner network, embedding risk-based governance, and enabling faster regulatory data exchange, we want to ensure that every molecule sourced through Aster reflects global compliance, uninterrupted execution, and long-term reliability.
In doing so, we move beyond transactional supply support to become an industry-recognized quality gatekeeper—one that global innovators, procurement teams, and regulatory authorities can depend on without hesitation.
India combines deep chemistry expertise, scale, regulatory maturity and cost efficiency. It is a critical pillar of the global API and intermediate supply chain.
Not all manufacturers are equal. Aster identifies audits and qualifies the facilities that consistently perform at the level required by global innovators and regulators – and then builds structured partnerships around them.
Every partner undergoes a structured, multi-stage qualification program designed to validate technical competence, operational integrity, and regulatory alignment. The process includes GMP audits, documentation reviews, compliance checks, and verification of quality systems to ensure readiness before onboarding.
Once approved, partners are monitored continuously through periodic audits, data trend evaluations, and performance scorecards. This ongoing oversight ensures sustained compliance, consistent product quality, and alignment with global regulatory standards throughout the lifecycle of engagement.
Partnering for Through our investment in new high volume chemistry tech, we have brought next generation.
We validate manufacturing capability and GMP alignment
We confirms transparency, traceability, and dossier readiness.
We track changes in compliance status and market expectations.
We confirm product integrity and release compliance for every batch.
We ensure material provenance, compliance assurance, and full traceability across every movement.
