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Active Pharmaceutical Ingredients (APIs)

Overview

Active Pharmaceutical Ingredients (APIs)

Agere Sciences specializes in the development and supply of high‑purity Active Pharmaceutical Ingredients (APIs). Our APIs form the biologically active foundation of finished pharmaceuticals, delivering therapeutic effects that improve and save lives. With decades of synthetic chemistry expertise and U.S.‑based manufacturing, we produce APIs that meet stringent quality standards and support drug discovery and clinical programs worldwide.

Capabilities

01

Custom Synthesis & Optimization

Whether you need mg‑scale samples for early R&D or kilogram‑scale lots for clinical supply, Agere can design and optimize synthetic routes that maximize yield and minimize impurities. Our chemists leverage advanced techniques—such as chiral synthesis, peptide coupling and complex heterocycle construction—to deliver the molecules your program requires.
02

Analytical & Purity Assurance

Each batch is subjected to thorough analytical characterization. We employ HPLC, NMR, LC‑MS and GC to confirm identity, potency and purity; we also perform impurity profiling to ensure compliance with regulatory guidelines. Certificates of Analysis accompany every shipment.
03

Flexible Production Scale

Our laboratories and pilot plant support seamless scale‑up from milligram samples to multi‑kilogram quantities. We can produce non‑GMP batches for toxicology studies and cGMP‑compliant batches for clinical trials and commercial use.
04

Regulatory Documentation

Comprehensive regulatory support is included with every API project. We prepare documentation that aligns with ICH guidelines, cGMP standards and relevant regulatory authority requirements. Our team assists with CMC dossier preparation and responds quickly to information requests.

Benefits

1
We adhere to cGMP and ISO‑aligned quality systems to deliver APIs with exceptional purity and batch‑to‑batch consistency.
2
Agile project management and efficient scale‑up mean you receive material when you need it, shortening your program’s timeline.
3
Throughout the synthesis and scale‑up process, our scientific advisors communicate openly with your team, ensuring your requirements are met and adjustments are made proactively.

Frequently Asked Questions

What information do I need to provide to request an API quotation?

We typically ask for the chemical structure or CAS number, desired quantity, required purity, regulatory status (e.g., non‑GMP, cGMP) and any special specifications. Sharing your timeline and intended use helps us tailor the proposal.

Do you manufacture APIs under cGMP conditions?

Yes. We operate under cGMP and ISO‑aligned quality systems. For clinical or commercial use, batches are manufactured and released according to cGMP requirements with full documentation.

What scales can you produce?

We synthesize APIs from milligram quantities for early research to multi‑kilogram lots for clinical and commercial supply. Our pilot plant allows seamless scale‑up while maintaining quality.

How do you ensure the purity and identity of APIs?

Each batch undergoes extensive analytical testing, including HPLC, NMR, LC‑MS and GC. We provide Certificates of Analysis that detail identity, potency and impurity profiles.

Can you develop a custom synthetic route for a novel API?

Absolutely. Our chemists design and optimise synthetic routes tailored to your molecule. We focus on scalable processes that maximise yield and minimise impurities.

What documentation do you provide for regulatory filings?

We supply comprehensive documentation, including batch records, analytical data, stability data and impurity profiles. Our team can prepare CMC sections for IND/CTA or NDA/MAA submissions.

How do you handle confidentiality and IP?

We operate under strict confidentiality agreements. All project information and intellectual property remain secure; we only share data with authorised contacts.

What is the typical turnaround time for an API project?

Timelines vary by complexity and scale. Early samples may take a few weeks, while process development and cGMP production can take several months. We work closely with you to align timelines with your program needs.

Do you offer stability studies for APIs?

Yes. We conduct stability studies under ICH guidelines to determine shelf life and storage conditions. This data can support regulatory submissions and product labeling.

Can you assist with technology transfer to a larger manufacturer?

If you need to transition production to a different facility for commercial volumes, we can prepare technology transfer packages and collaborate with the receiving team to ensure a smooth handover.

Ready to Start Your Project?

Ready to source reliable, high‑purity APIs? Contact our API team to discuss your project requirements or request a quote.
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