Biochemical APIs• Extensive expertise and almost 100 years experience in the
large scale extraction and purification of biochemical products from natural sources
• Own collection programs for starting materials using dedicated facilities and equipment for extraction and purification
• Through our long-lasting experience in the sourcing of raw materials from several continents, we have ensured full quality oversight, control and traceability
• Manufacturing processes include validated and approved viral and prion reduction steps
• In-house real time PCR analysis• Continuously monitoring of and involvement in changing
governmental regulations
Global Marketing & Sales Office
PO Box 98Kloosterstraat 6 5340 AB OssThe Netherlands
+31 88 277 97 79 [email protected] www.aspenoss.com
Sales Office USA / Canada
2136 South Wolf Road Des PlainesIL 60018United States of America
+1 847 635 09 85
[email protected] www.aspenoss.com
Sales Office Japan
Sumitomo Fudosan Kudan Bldg. 9F1-8-10 Kudan-kita, Chiyoda-kuTokyo 102-0073 Japan
+81 3 4588 7902
[email protected] www.aspenoss.com
World Class APIsAll our APIs are produced routinely and on commercial scale according to cGMP
Our facilities are regularly inspected andapproved by international health authoritiessuch as the US FDA, Dutch Health Authorities, PMDA and ANVISA
Through our extensive know-how we are able to offer consistently high quality products
Peptide APIs• 50 years of peptide experience• Batch to batch reproducibility combined with high yields
and purity profiles• Stainless steel and glass-lined reactors (100-1500 liters)• Extensive know-how and experience in both solution and
solid-phase synthesis• Patented green continuous method for large-scale manufacturing in
solution (GC-LPPS) • Ion exchange chromatography and reverse-phase preparative
HPLC columns up to 45 cm in diameter• Final isolation using tray lyophilizers with a capacity up to 100 liters
Chemical APIs• More than 100 stainless steel and glass-lined reactor
vessels (250-10,000 liters)• Multipurpose manufacturing through advanced planning
techniques and strict application of cleaning procedures• HPAPI production in units with OEB 4 and 5 classifications• Complex chemicals reactions: ethynylation, (ammoniacal)
reductions, oxidation, bromination and Grignard• Conversion of steroidal starting material through microbiological
fermentation • Large scale purification through crystallization, filtration and
chromatography• State-of-the-art unit for finishing, sieving, milling and micronisation
Commencement of biochemical API operations
Further expansion of chemical facility at Diosite
Acquisition of API operations by Aspen Holding
Upgrading and expansion of biochemical manufacturing capacity
Construction of state-of-the-art chemical facility (Diosite)
Expansion of peptide manufacturing capacity
Construction of new sieving, milling and micronisation facility at Diosite
1923
1995
2002
2005
2013
2015
2017
History Aspen Oss
Contact
World Class APIs
www.aspenoss.com
About Aspen Oss
Aspen Oss has a proud history in the production of APIs, spanning over almost 100 years. Aspen Oss specializes in the manufacture of highly complex APIs. We are dedicated to the production of high quality APIs and delivering extensive quality and regulatory support.
Aspen Oss performs approximately
400 unique processes annually
Produced at 3 API production sites
in the Netherlands
Resulting in a portfolio of
31 high quality APIs
Supported by approximately
800 employees
Our customers benefit from our extensive experience by receiving a high level of quality and regulatory support.
Our team with a broad range of experience is available to support you at all stages from development through registration and commercialisation.
• A long track record of regulatory compliance underpinned by strong relationships with governmental and regulatory agencies globally
• Global regulatory experience with more than 120 DMF’s filed• Active member of APIC and directly involved in discussions
within EMA, US FDA, EDQM and ICH• Representation in expert groups of both USP and Ph. Eur.
Extensive Support
Products
Can
ada
& USA Europe
Others Bra
zil
Ja
panOver
120 DMF’s worldwide
API CEP/ASMF
US-DMF J-DMF Brazil DMF
China DMF
Other 1
Biochemical APIs
Heparin Sodium ✔ ✔ ✔ ✔
Human Chorionic Gonadotrophin (HCG) ✔ ✔ ✔2
✔
Peptide APIs
Desmopressin ✔ ✔ ✔
Gonadorelin acetate (LH-RH) ✔ ✔ ✔
Gonadorelin diacetate tetrahydrate ✔
Leuprolide acetate (Leuprorelin) ✔ ✔ ✔ ✔ ✔
Oxytocin ✔ ✔ ✔ ✔
Chemical APIs - Estrogens
Conjugated Estrogens ✔2
Esterified Estrogens ✔
Estradiol ✔ ✔ ✔ ✔ ✔2
✔
Estradiol valerate ✔ ✔ ✔2
✔2
✔
Estriol ✔ ✔ ✔ ✔ ✔
Ethinyl estradiol ✔ ✔ ✔ ✔ ✔ ✔
Chemical APIs - Norsteroids and others
Desogestrel ✔ ✔ ✔ ✔ ✔
Ethynodiol diacetate ✔ ✔
Hydroxyprogesterone caproate 3 ✔ ✔ ✔
Lynestrenol ✔
Nandrolone decanoate ✔ ✔ ✔ ✔
Norethindrone ✔ ✔ ✔ ✔ ✔
Norethindrone acetate ✔ ✔ ✔ ✔ ✔
Progesterone ✔ ✔ ✔ ✔2
✔
Tibolone ✔ ✔ ✔
Chemical APIs - Testosterones
Testosterone ✔ ✔ ✔ ✔
Testosterone cypionate (cyclopentylpropionate) ✔ ✔
Testosterone decanoate ✔ ✔2
✔
Testosterone isocaproate ✔ ✔2
✔
Testosterone phenylpropionate ✔ ✔2
✔
Testosterone propionate ✔ ✔2
✔
Testosterone undecanoate (undecylate) ✔ ✔ ✔
Chemical APIs - Other APIs
Mirtazapine ✔ ✔ ✔ ✔ ✔
Rocuronium Bromide ✔ ✔ ✔ ✔ ✔ ✔
Chemical APIs: development upon request Peptide APIs: development upon request
Dydrogesterone Obeticholic acid Etelcalcetide
Naloxone HCl Segesterone
Naltrexone HCl Testosterone enanthate
Specific Disclaimer. Some of these active ingredients could be protected by a patent in force and would be therefore developed on request exclusively
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
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
applicable laws and regulations. This information is provided to you solely for your evaluation, to determine your interest in a potential relationship with
Aspen Oss B.V.
1) other can include Canada, Russia, India, etc. 2) in progress 3) only available for selected countries.
General Disclaimer. Aspen Oss makes no representation, guarantee or warranty as to, including, without
limitation: (i) the completeness or accuracy of the information provided herein; and (ii) the patentability of the
products mentioned or defense from action for infringement of any third party intellectual property rights,
and Aspen Oss B.V. assumes no liability therefore.
Last update October 2019.
BooQi products are produced under license andare subject to design registrations and trademarks.© Booqi Media Solutions BV www.booqi.comcall +31 (0)20 7163151 NO 41523/31