TRUSTED SUPPLIER of Active Pharmaceutical Ingredients

CDMO

CONTINUUM OF PROGRESSAPIs

D-SerineUsing in-house biocatalysis technology, SEQENS has developed a direct synthesis of D-Serine.

Ketamine product family:SEQENS has developed the full range of products in the ketamine family: Hydrochloride and free base, racemic and each chiral pure product (S-Ketamine and R-Ketamine).

SEQENS CDMO is a global leader in the production of Active Pharmaceutical Ingredients. The company has over 25 years of experience in developing and producing high-quality Active Pharmaceutical Ingredients using first class R&D and proprietary technology such as biocatalysis to develop unique processes.

More than 50 APIs have been successfully launched in the United States, Europe and Japan with consistently superior quality, reliability and customer service, supported by regulatory documentation to meet the most stringent standards from local agencies.

Customers benefit from a manufacturing network of 6 cGMP plants located in Europe and the United States with a strong regulatory track record with international health authorities such as the FDA, European and Japanese authorities.

SEQENS ASSETS

Over 50 years of API production experience 600m3 of cGMP production capacity Excellent regulatory compliance track record at all GMP sites Over 30 Quality Assurance professionals In-house back integration of intermediates and starting material for safe supply One API source with worldwide regulatory filing capability and experience Global sales and distribution network

Products Highlight

Products Under Development

6FDA/EU/PMDA INSPECTED SITES

GMP production from grams to multi-ton commercial scale: Germany - Lahr France - Aramon France - Limay France - Villeneuve-La -Garenne Finland - Turku

US - Newburyport, MA

WORKSHOP AND EXPERTISE IN SPECIALIZED TECHNOLOGIES

High Pressure Reaction Low temperature technology Ethylene Oxide under GMP API for injectable and ophthalmic FDF Potent API capabilities: OEL<100 ng/m3

Chromatography

3 PRE GMP SITES FOR IN-HOUSE PRODUCTION OF RSMs AND INTERMEDIATES

Production from kilograms to multi-ton commercial scale: France - Couterne France - Bourgoin Germany - Lahr

Product FDA / EMA approved IndicationD-Serine Under clinical evaluation Neuroplasticity - Schizophrenia

Esmolol HCl 1988 Atrial fibrillation

Glycopyrrolate Tosylate Under Clinical evaluation Anticholinergic, Hyperhidrosis

Mefenamic Acid Generic Analgesic

Methoxsalen Generic Antifungals, Antipsoriatics

Metolazone Generic Diuretic

Norketamine Under development Pain

Safinamide 2017/ 2015 Add-on treatment for Parkinson’s disease

Ursodiol 1987 / 1980 Primary biliary cirrhosis

R-Ketamine HCl Under development Depression, Pain management

R-Praziquantel Under Clinical evaluation Anthelmintic

S-Ketamine Base Under development Depression, Pain management

Sodium Benzoate Under Clinical evaluation Urea Cycle Disorders, Schizophrenia

Toremifene citrate 1997 Antineoplastic

1,000 M2 lab-floor5 Kilo Labs

DEVENS, MA (USA) PORCHEVILLE (FRA)

30 Scientists with > 50% PhD

2,000 M2 lab-floor6 Kilo Labs110 Scientists with > 50% PhD

PROTEUS (FRA)

1,000 M2 Lab floor8,000 Micro-organisms library 350 Enzymes available for testing

/ Controlled substances (Schedule II-V)

/ Biocatalysis/ Tailor made enzymes

20 Scientists with > 30% PhD

Global devlopement center for new API project launch in Europe and US

/ Crystallization/solid state characterization/ Multidisciplinary teams and network with an available space for neighbor companies/ Capacity to produce from a few milligrams to 100 kg per batch / In-house Regulatory Affairs team with world- wide filing capacity and experience: more than 80 active DMFs / Solid state development team: Expertise in polymorphism / Customized particle size distribution / In-house IP team for the design of non-infringing patent process

Product Quality Europe CEP

Europe DMF

(ASMF)US DMF US DMF for

reference **Canada

DMFJapan DMF

China DMF Indication

Aminocaproic acid ◊ /

Apraclonidine HCl USP / Intraocular pressureArticain (Carticaine) HCl Ph.Eur / / /* Anaesthetic (local)

Atropine SulphateAzelaic Acid / AcneBaclofen Ph.Eur, USP / / / / Muscle relaxant (skeletal)Cadexomer IodineCicletanine / / AntihypertensiveCiclopirox Ph.Eur, USP / / / AntifungalCiclopirox Olamine Ph.Eur, USP / / Antifungal

Cinacalcet / / / /Treatment of hypercalcemia

Clodronate disodium Ph.Eur /* Calcium regulator, Osteoporosis

Clomifene Citrate Ph.Eur, USP, JP / / /* /

Gonad-stimulating principle

Clonidine Base USP / / AntihypertensiveClonidine HCl Ph.Eur, USP / / / / /* AntihypertensiveCytisine2,4-Dichlorobenzyl alcohol Ph.Eur / Mild Anaesthetic (local)

Dapagliflozin /

Dapsone /

Desipramine HCl Ph.Eur, USP / / AntidepressantDexchlopheniramine Maleate N/A

Disopyramide Phosphate Ph.Eur, USP / Antiarrhythmic

Disulfiram /

Divalproex Sodium USP / / /Anticonvulsant, Antimigraine

Dorzolamide HCl Ph.Eur, USP / / / / Antiglaucoma agentDoxorubicin LiposomalEnclomiphene citrate / / Testosterone deficiency Esomeprazole Magnesium Ph.Eur, USP / / / /*

Gastroesophageal reflux disease

Esomeprazole Sodium / / /* Gastroesophageal reflux disease

Ethacrynic Acid ◊ /

FelbamateFlecainide Acetate /

Flucytosine ◊ /

Galantamine /Glycopyrrolate Bromide Ph.Eur, USP / / / / / /* COPD, AntispasmodicGlycopyrrolate Bromide

Inhalation PSD /* /* /* COPD

Heptaminol Base AntihypotensiveHeptaminol HCl Ph.Eur / AntihypotensiveHydralazine HydrateHyoscyamineKetamine HCl Ph.Eur, USP / / / / Anesthetic Kinetin N/AMepenzolate Bromide JP / / AntispasmodicMepivacaine HCl Ph.Eur, USP / /* Anaesthetic (local)Mequitazine EP (int.), JP / / AntihistaminicMethenamine Hippurate USP /* /* Antibacterial (urinary)

Methenamine Maleate N/AMethimazole (Thiamazol) Ph.Eur, USP / / / / / /* Hyperthyroidism Methscopolamine BromideMethscopolamine Nitrate /

Miglustat ◊ /

Miglitol /

SEQENS’ API Product list

MitotaneMoexipril HCI /* Antihypertensive

Olopatadine HCl Ph.Eur, USP / / /* Antiallergic, Antithistaminic

Oxeladin Citrate Ph.Eur /Antitussive (non-opiod)

Oxybutynin Base / / / / Urinary incontinenceOxybutynin HCl Ph.Eur, USP / / / / / /* Urinary incontinence PhenoxybenzaminePhenylacetic acid sodium salt (Sodium phenyl acetate)

/ / Urea cycle disorders

4-Phenylbutyric acidsodium salt (Sodiumphenylbutyrate)

Ph.Eur /* /* / Urea cycle disorders

Pholcodine Ph.Eur / / Antitussive

Pindolol Ph.Eur, USP / / / /Antihypertensive, Antiarrhythmic

Piperidolate HCl / Antispasmodic

PLGA polymers Expansorb® / /* Excipient , Drug delivery

Podophyllotoxin /

Praziquantel Ph.Eur, USP / / / / AnthelminticPromazine HCl Ph.Eur /* / AntipsychoticPromethazine Base / Antihistaminic

Pyridostigmine Bromide /

Racecadotril / Antidiarrheal

R-Baclofen /* Muscle relaxant, Antispastic

R-Oxybutynin HCl Urinary incontinence

S-Ketamine HCl Ph.Eur / / / / Anesthetic, DepressionSodium Ethacrynate ◊ /

Sodium Nitroprusside ◊ /

Sodium Phenyl Acetate Urea cycle disorders Sodium Phenyl Butyrate /* / / Urea cycle disorders Tamoxifen Citrate Ph.Eur, USP /* /* /* / AntineoplasticTazarotene / / / Antiacne, Antipsoriatic

Terazosin HCl Anhydrous /

Tetrahydrozoline Ph.Eur, USP, JP /* / Vasoconstrictor

Timolol Hemihydrate / /Antiglaucoma, Antihypertensive

Timolol Maleate Ph.Eur, USP / / / / /Antiglaucoma, Antihypertensive

Trimeprazine (Alimemazine) Tartrate Ph.Eur, USP / / / Antipruritic

Troxerutine Ph.Eur /Treatment of venous disorders

Vitamin E TPGS Ph.Eur, USP Excipient and Drug Delivery

Vitamin K1 (phytonadione) ◊ /

Zonisamide /

CONTACT US :APIS-US.cdmo@seqens.com APIS-EUROPE.cdmo@seqens.com APIS-ASIA.cdmo@seqens.com APIS-ROW.cdmo@seqens.com

21 CHEMIN DE LA SAUVEGARDE21 ECULLY PARCCS 3316769134 ECULLY CEDEX - FRANCETEL. +33(0)4 26 99 18 00

* In progress. ** US DMFs that have passed the Completeness Assessment and are available for reference by ANDAs under GDUFA. Availability of APIs is subject to patent restriction in countries where applicable patents are in effect ◊ Available for markets other than the US.

Product Quality Europe CEP

Europe DMF

(ASMF)US DMF US DMF for

reference **Canada

DMFJapan DMF

China DMF Indication

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