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Case Studies
At Lantaris, we’ve helped numerous generic pharmaceutical manufacturers optimize their API sourcing. Here are some of our success stories.
Success Stories in API Sourcing
Salvaging a Critical Launch and Achieving Significant Savings
Client: Major Multinational Generic Manufacturer, headquartered in Taiwan
Challenge: During the EU regulatory review period, the client’s sole API supplier failed a GMP compliance audit, posing a significant risk to the approval timeline.
Our Approach:
- Conducted comprehensive supplier discovery
- Vetted potential suppliers for compliance, quality, and reliability
- Negotiated favorable contract terms
- Organized third-party GMP audits for short-listed suppliers
Result: Two alternative, GMP-compliant manufacturers were identified, qualified and submitted to the EU authorities during the regulatory procedure, leading to a 38% cost reduction and improved supply security, with minimal delay in the approval timeline.
Accelerating Time-to-Market
Client:Medium-Sized Asian Generic Manufacturer
Challenge: A patent revocation unexpectedly opened the South-Korean market for a generic molecule, prompting the client to source a high-quality API quickly to outpace competitors.
Our Approach:
- Leveraged our global network to identify potential suppliers swiftly
- Expedited the vetting and negotiation process
- Organized and attended a GMP-audit at the supplier site in record time
- Collaborated with a local regulatory agent for expedited DMF filing
Result: The client sourced the API and initiated development rapidly, launching their generic product five months ahead of competitors.
Unlocking a Niche Market Opportunity
Client: Medium-Sized European Generic Manufacturer
Challenge: The client targeted a unique opportunity for a generic product marketed only in Poland, but sourcing the API proved challenging due to economic feasibility concerns.
Our Approach:
- Conducted an extensive global search for API manufacturers
- Explored alternative manufacturing methods beyond chemical synthesis
- Identified a small Chinese developer open to a fermentation approach
- Organized and participated in the GMP audit
- Negotiated an exclusive development and manufacturing agreement
- Monitored development, validation, and DMF filing closely
Result: The client secured a competitive API source, launched their product at 45% lower price than the originator and captured 70% market share within two years.
Improving Supply Chain Reliability
Client:Medium-Size European Generic Company
Challenge: The client faced frequent delays and quality issues with their existing API supplier
Our Approach:
- Analyzed the client’s requirements
- Identified alternative suppliers in different geographic regions
- Conducted thorough vetting process and facilitated GMP audits
- Helped the client select the two most suitable suppliers
Result: The client established relationships with two reliable suppliers, enhacing supply chain stability and eliminating delivery delays.
