Post on 10-Oct-2020
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
WWW.SEQENS.COM