Peptide-based generics


Peptide-based generics


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Products & Services | Bachem AG

Overview

Bachem is the world´s leading independent manufacturer of peptides used as active pharmaceutical ingredients (APIs) used in the fields of cancer, diabetes, obesity, fertility and many more. Bachem offers a range of some 40 generic products of which more than 25 are peptides.

Bachem’s manufacturing capacity allows it to produce generic peptide APIs in quantities of hundreds of kilograms per year. Its GMP manufacturing facilities are located in Switzerland and the United States and are regularly inspected by the FDA and local authorities.

Blockbusters

As a long time respected supplier to the pharmaceutical industry, Bachem APIs and peptide-based ingredients have been used in the production of several blockbuster drugs that are now becoming available as generics.

Goserelin:
Goserelin is a potent GnRH (LHRH) agonist. It is used in therapy against advanced hormone-dependent prostate cancer. Bachem has worked in close co-operation with AstraZeneca, supplying the Goselrin for the blockbuster drug Zoladex for more than 20 years. How, however, Bachem is also able to offer this valuable API to generic manufacturers. Bachem is also in position to offer regulatory support with Drug Master File (DMF) and Certificate of suitability to the monographs of the European Pharmacopoeia (CEP).

Leuprolide:
Bachem is also able to offer the alternative API Leuprolide, which is from the same product family as Goserelin and used for the same indication. Again, Bachem can supply on a large commercial scale with DMF and CEP regulatory support.

New and future products

Bachem also has recently introduced generics and others under development.

Atosiban:
Atosiban is an oxytocin and vasopressin antagonist that is useful in the management of pre-term childbirth. Bachem has fully developed this API at its state-of-the-art cGMP manufacturing site in Switzerland. A DMF is available and is currently being filed in Europe and other states. A modern manufacturing process is also available that allows Atosiban to be produced on a commercial scale.

Lanreotide:
Lanreotide is a synthetic analog of Somatostatin with properties similar to Octreotide. Bachem has successfully commenced development of this API, with the first batch manufactured to GMP standardsin the second half of 2014. Bachem is currently planning further development of Lanreotide. With representative cGMP grade material gathered from initial synthesis now in stock, Bachem is now ready to explore commercial development with partners.

Disclaimer

All APIs that are sold for development of drug products still under patent protection are offered under Bolar Exemption only. These products are only offered and sold in small quantities and solely for uses reasonably related to privileged trials and studies for obtaining marketing authorization required by law (Bolar Exemption). Bachem cannot be made liable for any infringement of intellectual property rights. It is the sole and only responsibility of the purchaser or user of these products to comply with the relevant national rules and regulations.

Discounts

Visit the Bachem online catalog to see the full collection of peptides, building blocks and biochemicals, all available for fast delivery.
Pharmaceutical Networking users qualify for an exclusive 10% discount on the online SPPS products featured here.
Just enter promotional code PN10 when placing your order to receive these special discounted prices.

Resources

Click on Bachem Generics for more information.
Click on
Bachem’s Online Shop to see the full catalog.
Click on Bachem to contact the company directly.


Supplier Information
Supplier: Bachem AG
Address: Hauptstrasse 144, 4416 Bubendorf, Switzerland
Tel: +41 61 935 2323
Fax: +41 61 935 2325
Website: www.bachem.com


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