By Bachem AG
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Bachem generic drug development
Bachem AG leverages its half-century experience in active pharmaceutical ingredient development and advanced manufacturing capabilities to offer a wide range of complex generic APIs in comprehensive packages that meet all customer regulatory, quality, and logistical needs.
Generics are often seen as only ‘commodity’ copies of previously patented drugs but in fact have real quality attributes and distinctive features. Making generics is complex and requires mastering a broad range of skills – from the legal aspect of acquiring new products for the portfolio, to quickly bringing safe products to market. Effective generics are marked out by deep development experience, advanced manufacturing processes, supported by effective quality, regulatory and filing services, along with efficient distribution.
Bachem is highly aware of the challenges faced by generic producers who must deliver the right products, at the right time, and at the right cost while ensuring product safety. This leaves little or no room for inefficiency and it is of the utmost importance to find the right partner to help their business to successfully deliver their generic masterpiece.
Going the extra mile
Thus, creating active pharmaceutical ingredients (APIs) for generics demands much more than simply following a recipe. The support and services around the molecule are critical. With its passion and expertise, Bachem can offer customers all the elements required for a worry-free API supply experience and successful launch.
Challenges in generics are not typically solved by a single service offering, but through a multidisciplinary approach, which enhances commercial success though innovation and operational excellence and manages risk, regulatory, and compliance issues. Therefore, Bachem goes the extra mile to offer comprehensive services and an all-around positive experience to its customers.
Over its more than 50-year history, Bachem has built up outstanding regulatory expertise that enables it to provide complete generic API packages that are market-ready, as part of an unmatched portfolio approach including comprehensive documentation.
The Bachem ethos of constant Innovation is applied to continuously improve generic manufacturing processes and efficiency, applying new technologies to meet emerging generic API opportunities at high quality, minimized lead time and the right cost.
Partner of choice
Bachem can fulfil customer needs from a few grams to multi-kilograms to tenth of tons of generic API with timely delivery. Crucially, because Bachem manufactures some of its own raw materials, it is better able to ensure a safe and sustainable supply chain.
With its proven ability to manufacture complex APIs and meet the most stringent quality requirements plus its almost unrivalled track record of regulatory experience, Bachem has established itself as the partner of choice for generic drugs.
Bachem prefers a collaborative approach, working in partnership with customers to tackle challenges to ensure the most cost-effective medicine provision to patients.
The Bachem approach also includes simplifying partners’ lives wherever possible by reducing the complexity of manufacturing and focusing on mutual success. Continuous investment in capacity and automation for higher quality and sustainability makes Bachem the perfect partner for a demanding project.
Bachem produces one of the world’s widest ranges of commercially available synthetic peptide APIS . It currently manufactures close to a third of the 75 peptide APIs currently approved worldwide for use in in commercial drugs for the treatment of diverse diseases, either as new chemical entities (NCEs) or generics.
Bachem’s status as reliable, independent and financially strong company has made it an attractive long-tern partner for leading pharmaceutical companies, such as AstraZeneca and Debiopharm, with many long-term supply agreements on generic APIs in place.
Bachem’s range of peptide-based APIs are manufactured in Switzerland and the USA and are supported by Drug Master File (DMF), Certificate of Suitability (CEP) or both. Leading generic products include:
|Buserelin||DMF||Oncology, Reproductive Medicine||CH|
|Calcitonin||Paget‘s disease, Hypercalcemia and Osteoporosis||USA|
|Gonadorelin Acetate||CEP / DMF||Oncology, Reproductive Medicine||CH|
|Goserelin Acetate||CEP/DMF||Oncology, Reproductive Medicine||CH|
|Icatibant Acetate||DMF||Hereditary Angioedema||CH|
|Teriparatide Acetate / pTH (1-34) (human)||DMF||Osteoporosis||USA|
|Triptorelin Acetate||DMF||Oncology, Reproductive Medicine||CH|
|Triptorelin Pamoate||DMF||Oncology, Reproductive Medicine||CH|
Small molecule APIs
Bachem also manufactures small molecule API at its site in Vionnaz, Switzerland, and sold in quantities down to 100 kilos. These include:
|Carbidopa||CEP, DMF||Epilepsy and Parkinson‘s Disease||CH|
|Etomidate||CEP, DMF||Sedatives and Anesthetics||CH|
|Propofol||CEP, DMF||Sedatives and Anesthetics||CH|