World Class APIs Contact
All our APIs are produced routinely and on Global Marketing Sales Office Liaison Office commercial scale according to cGMP & Sales Office USA / Canada Japan
Our facilities are regularly inspected and PO Box 98 2136 South Wolf Road Level 11, Aoyama Palacio Tower approved by international health authorities Kloosterstraat 6 Des Plaines 3-6-7 Kita-Aoyama, Minato-ku 5340 AB Oss IL 60018 Tokyo 107-0061 such as the US FDA, Dutch Health Authorities, The Netherlands United States of America Japan PMDA and ANVISA +1 847 635 09 85 +81 3 5464 8634 +31 88 277 97 79 aspenapi-usa@ Through our extensive know-how we are able aspenapi-japan@ [email protected] us.aspenpharma.com nl.aspenpharma.com to offer consistently high quality products www.aspenoss.com www.aspenoss.com www.aspenoss.com World Class APIs
Biochemical APIs Peptide APIs Chemical APIs • Extensive expertise and almost 100 years experience in the • 50 years of peptide experience • More than 100 stainless steel and glass-lined reactor large scale extraction and purification of biochemical • Batch to batch reproducibility combined with high yields vessels (250-10,000 liters) products from natural sources and purity profiles • Multipurpose manufacturing through advanced planning • Own collection programs for starting materials using dedicated • Stainless steel and glass-lined reactors (100-1500 liters) techniques and strict application of cleaning procedures facilities and equipment for extraction and purification • Extensive know-how and experience in both solution and • HPAPI production in units with OEB 4 and 5 classifications • Through our long-lasting experience in the sourcing of raw solid-phase synthesis • Complex chemicals reactions: ethynylation, (ammoniacal) materials from several continents, we have ensured full quality • Patented green continuous method for large-scale manufacturing in reductions, oxidation, bromination and Grignard oversight, control and traceability solution (GC-LPPS) • Conversion of steroidal starting material through microbiological • Manufacturing processes include validated and approved viral • Ion exchange chromatography and reverse-phase preparative fermentation and prion reduction steps HPLC columns up to 45 cm in diameter • Large scale purification through crystallization, filtration and • In-house real time PCR analysis • Final isolation using tray lyophilizers with a capacity up to 100 liters chromatography • Continuously monitoring of and involvement in changing • State-of-the-art unit for finishing, sieving, milling and micronisation governmental regulations
History Aspen Oss
Construction of state-of-the-art Construction of new sieving, milling Expansion of peptide chemical facility (Diosite) and micronisation facility at Diosite manufacturing capacity 1923 2002 2013 2017 www.aspenoss.com Commencement Further expansion Acquisition of API Upgrading and expansion of biochemical 1995 of chemical 2005 operations by 2015 of biochemical API operations facility at Diosite Aspen Holding manufacturing capacity 1 About Aspen Oss Products API CEP/ US-DMF J-DMF Brazil China Other ASMF DMF DMF Biochemical APIs Aspen Oss has a proud history in the production of Heparin Sodium ✔ ✔ ✔ ✔ APIs, spanning over almost 100 years. Aspen Oss Human Chorionic Gonadotrophin (HCG) ✔ ✔ ✔2 ✔ specializes in the manufacture of highly complex APIs. Peptide APIs Desmopressin ✔ ✔ ✔ We are dedicated to the production of high quality APIs Gonadorelin acetate (LH-RH) ✔ ✔ ✔ and delivering extensive quality and regulatory support. Gonadorelin diacetate tetrahydrate ✔ Leuprolide acetate (Leuprorelin) ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ Aspen Oss performs Oxytocin Chemical APIs - Estrogens approximately Conjugated Estrogens ✔2 Esterified Estrogens ✔ 400 unique processes Estradiol ✔ ✔ ✔ ✔ ✔2 ✔ annually Estradiol valerate ✔ ✔ ✔ ✔2 ✔ Estriol ✔ ✔ ✔ ✔ ✔2 ✔ Ethinyl estradiol ✔ ✔ ✔ ✔ ✔ ✔ Chemical APIs - Norsteroids and others Produced at 3 API Desogestrel ✔ ✔ ✔ ✔ ✔ production sites Ethynodiol diacetate ✔ ✔ Hydroxyprogesterone caproate 3 ✔ ✔ ✔ in the Netherlands Lynestrenol ✔ Nandrolone decanoate ✔ ✔ ✔ ✔ Norethindrone ✔ ✔ ✔ ✔ ✔ Resulting in a portfolio of Norethindrone acetate ✔ ✔ ✔ ✔ ✔ Progesterone ✔ ✔ ✔ ✔2 ✔ 31 high quality Tibolone ✔ ✔ ✔2 ✔ APIs Chemical APIs - Testosterones Our customers benefit from Testosterone ✔ ✔ ✔ ✔ our extensive experience Testosterone cypionate (cyclopentylpropionate) ✔ ✔ 2 by receiving a high level Testosterone decanoate ✔ ✔ ✔ Supported by approximately ✔ ✔2 ✔ of quality and regulatory Testosterone isocaproate 800 employees Testosterone phenylpropionate ✔ ✔2 ✔ support. Testosterone propionate ✔ ✔2 ✔ Testosterone undecanoate (undecylate) ✔ ✔ ✔ Chemical APIs - Other APIs Mirtazapine ✔ ✔ ✔ ✔ ✔2 ✔ Extensive Support Rocuronium Bromide ✔ ✔ ✔ ✔ ✔ ✔
Chemical APIs: development upon request Peptide APIs: development upon request Dydrogesterone Segesterone acetate Etelcalcetide Our team with a broad range of experience is available Nomegestrol acetate Testosterone enanthate Goserelin to support you at all stages from development through E A ur Specific Disclaimer. Some of these active ingredients could be protected by a patent in force and would be therefore developed on request exclusively S op registration and commercialisation. U e for the purposes stated in Article 10.6 of the Directive 2001/83/EC as amended by the Directive 2004/27/EC (Bolar provision). No activity will be performed & with the active ingredients protected by a patent in force beyond the scope of the Bolar provision in any concerned jurisdiction. Nothing herein should be a construed as an offer or promotion or advertisement for the sale or use of any product, if such sale or use infringes valid patents and is not authorized under • A long track record of regulatory compliance underpinned by d a Over applicable laws and regulations. This information is provided to you solely for your evaluation, to determine your interest in a potential relationship with strong relationships with governmental and regulatory agencies n n a
120 DMF’s a Aspen Oss B.V. C p
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• Global regulatory experience with more than 120 DMF’s filed
1) other can include Canada, Russia, India, etc. 2) in progress 3) only available for selected countries. l • Active member of APIC and directly involved in discussions i z Last update March 2020. O ra General Disclaimer. Aspen Oss makes no representation, guarantee or warranty as to, including, without within EMA, US FDA, EDQM and ICH th B er limitation: (i) the completeness or accuracy of the information provided herein; and (ii) the patentability of the BooQi products are produced under license and • Representation in expert groups of both USP and Ph. Eur. s are subject to design registrations and trademarks. products mentioned or defense from action for infringement of any third party intellectual property rights, © Booqi Media Solutions BV www.booqi.com and Aspen Oss B.V. assumes no liability therefore. call +31 (0)20 7163151 NO 41523/31