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 api@nl.aspenpharma.com www.aspenoss.com

Sales Office USA / Canada

2136 South Wolf Road Des PlainesIL 60018United States of America

+1 847 635 09 85

aspenapi-usa@us.aspenpharma.com www.aspenoss.com

Sales Office Japan

Sumitomo Fudosan Kudan Bldg. 9F1-8-10 Kudan-kita, Chiyoda-kuTokyo 102-0073 Japan

+81 3 4588 7902

ajp.api@jp.aspenpharma.com 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