Development of generic APIs
Axplora has more than 50 years of experience in generic API development and manufacturing. We offer a wide range of API products that addresses respiratory, inflammatory, or liver diseases.
We are constantly broadening and expanding our generic pipeline with new molecules in new and growing therapeutic areas such as oncology and CNS to help our clients to deliver the best medicines to their patients worldwide.
A recognized expertise in generic API developement and production
Axplora has successfully brought to market many generic APIs worldwide, supported by regulatory documentation to meet the most stringent standards from local agencies.
With more than 120 R&D scientists across 3 continents, specialized in the design of competitive, innovative, and sustainable Routes of Synthesis (RoS), we have the capacity and expertise to bring the safest and cost-efficient generic APIs to market, and to handle regulatory filings at every stage and in all markets.
Thanks to our Scientific Advisory Board, bringing together leading international experts with complementary areas of expertise, spanning from catalysis, electrochemistry, steroids to biochemistry, Axplora will reinforce its expertise and strengthen the deployment of innovative and sustainable technologies and modalities for its customers.
Our services for generic APIs
Axplora can assist you from the preliminary design of the synthetic route and feasibility at milligram scale to the GMP-compliant and validated technological process.
Our experienced and fully trained team supports QbD approaches, process characterization & control strategy and ensures the best process development:
- Process development
- Synthetic route design
- Process development and optimization
- Determination of critical parameters & control strategy to improve yield & reach quality target
- Scale-up and validation
- Modeling to ensure a robust and smooth scale-up
- Process validation
- Manufacturing
- cGMP manufacturing
- Continuous improvement
- Analytical development: analytics forms the bedrock of our offering:
- Analytical method development, transfer, and validation
- Sampling, testing and release of incoming raw materials
- IPCs and release testing
- Elemental, Nitrosamines and other impurities testing in compliance with ICH Q3D guidelines
- Reference standards characterization
- Structural identification of impurities
- Stability studies
Our strong expertise in organic chemistry combined to a large toolbox of technologies such as flow chemistry and electrochemistry allow our teams to propose the best generic API process development in a competitive time frame.
Generic APIs and intermediates under development at Axplora
Axplora is continuously developing new generic APIs (subject to short-term changes due to market demand).
Our current development pipeline includes:
- Methylprednisolone base
- Methylprednisolone hydrogen succinate
- Mometasone furoate monohydrate
- Estetrol
- Segesterone acetate
- Bile acid derivatives
- Chenodeoxycholic acid
- Cholic acid
- Isavuconazonium sulfate
- Pinaverium bromide
- Betahistine hydrocholride
Find out more in our API Product portfolio and for more information, connect with our experts.
Supporting technologies for generic API development
At Axplora, innovation is ingrained in our DNA and central to our corporate mission. We embrace a culture of exploration, collaborating closely with universities, research centers and our Scientific Advisory Board.
We have long been working on developing and implementing new sustainability and greener technologies. We currently offer a toolbox of more than 15 technologies to customers, ranging from chromatography to continuous processes, ADCs, biocatalysis or electrochemistry.
This allows us to have broad possibilities in the design of competitive, novel, and robust routes of synthesis for our generic APIs. Most of the technologies help us also to accelerate development, operate more efficiently and develop more sustainable processes to better serve our customers.
Listen our podcast to discover how we foster innovation and drive R&D at Axplora.
Our sites involved in generic API development
3 of our sites are experienced in developing generic APIs:
Our Gropello site, in Italy, has a strong expertise in the development, scale-up and manufacturing of steroidal generic molecules (sterile and non-sterile) and high potent compounds.
It’s the center of Excellence for solid form and particle size design.
Our Raubling site located in Germany offers development, scale-up and manufacturing services of generic APIs with customized particle sizes and physical properties. It benefits from a unique experience in operating electro-chemistry and enzymatic reactions at multi-ton scale.
Expert in process development, pilot and large-scale commercial production of generic APIs, our Vizag site located in India can also develop processes for highly potent compounds.
Depending on the needs, generic APIs development and manufacturing can also be performed in our other sites located in Europe and in our other Indian site in Chennai.
Discover our full API product portfolio:
