focusing on green & sustainable technology… MANAGEMENT TEAM
Mr. HARSHADRAI MEHTA ,isa Mr. DEVENDRA H MEHTA is a CEO, Mr. YOGIN H MEHTA is a COO ; CMD. He is the founder of his focus on Business Development, He has 24 years of rich Mehta Group. With over five In/Out licensing, Intellectual experience in Plant operation, decades of dedicated work and property development, Strategic Strength is execution , adopting a wealth of experience in the alliances, Eco friendly technology, new technologies continuous API Manufacturing field. He is with 25 years of rich experience. improvement in operating cost , the driving force behind MAPL’s capacity enhancement with help success & mentoring 2nd of team, laying emphasis on eco generation for successful friendly technology & quality growth. compliance.
Contributing to Good Health for Good Life CORPORATE OVERVIEW
Vision Mission • To make people smile by contributing to better health • Eco – friendly and go‐green culture integrating with excellent • Contributing to Good Health for technology, development and Good Life. manufacturing • Customer Centric Approach • Competent Team for management and execution • Supplier Development • CGMP Facility.
Core Culture Core Values Webelieve in an environment that: • Integrity • promotes performance • Transparency • nurtures team work • Proactively manage change • strengthens quality consciousness • Develop entrepreneurs through an • encourages transparencies achievement‐oriented culture • facilitates professional growth • Build an education savvy business environment • Share knowledge and focus on end results Contributing to Good Health for Good Life COMPANY PROFILE
2‐ CEP 2 ‐CEP Filed 12‐EDMF Filed (30 Countries) Project Management, CRAMS & CMO In Regulated Market 4‐ Under Pipeline . since 2003
Export products in more 3‐ Process Patent than 40 countries Filed Spanning 6 Continents More in Pipeline MEHTA API Manufacturing Capacity Block A ‐ Tonnage Serving Since 1970 EU‐GMP, EDQM, Block B ‐ Medium Manufacturing APIs, TGA, WHO ‐GMP Block C – Small HAPIs, Advanced Block D‐ HAPIs intermediates
Contributing to Good Health for Good Life MEHTA API PLANT
D B A C
BLOCK “A” with Large Volume Products BLOCK “B” for Medium Scale Production
BLOCK “C” with different Facilities and BLOCK “D” is dedicated Production Area Capabilities for Small Scale Production for HAPI with isolator Department
Contributing to Good Health for Good Life CMO BUSINESS
MANUFACTURING OF APIS , HAPIs AND ADVANCED INTERMEDIATES
CRAMs PATENT OUT CORE LICENCING BUSINESS & CMO
FDF DOSSIER PMV LIFE SCIENCE
Contributing to Good Health for Good Life EXPORT MARKET
Europe Asia MENA Africa
Austria Slovenia Bangladesh Sri Lanka Egypt Ghana
Belgium Spain Hong Kong Taiwan Iran Kenya
Cyprus UK Indonesia Thailand Iraq South Africa
Finland Latin America S. Korea Vietnam Israel Sudan
Ireland Brazil Japan Jordan Tanzania
Poland Mexico Malaysia CIS Syria Zimbabwe
Romania Guatemala Philippines Belarus UAE
Turkey America Pakistan Russia Australia
Switzerland Canada Singapore
Contributing to Good Health for Good Life CONTRACT RESEARCH & MANUFACTURING
Working under confidentiality agreement.
Non infringing process & Patentable process
Highly qualified and experienced chemists
Cost efficient processes of API & advance intermediates using green chemistry
High quality product meeting ICH guidelines and customer specification
Polymorph studies
Technology transfer
High potent API
Contributing to Good Health for Good Life APPROVALS AND CERTIFICATES
APPROVALS & CERTIFICATES VALIDITY
Manufacturing License from FDA (Maharashtra state) 19/10/2017 GMP Certification from FDA (Maharashtra State) 03/06/2017 WHO Certification 19/06/2017 Manufacturing Site’s D‐U‐N‐S No 650656957 Registered Office D‐U‐N‐S No 869493571 Block A and Block B approved by EDQM, Swiss Medic (Pics) and TGA Plant audited on 7/8/9th December 2012. CEP – Erythromycin Base RO‐CEP 2009‐267‐Rev‐01 CEP‐ Bisoprolol Fumarate RO‐CEP‐2013‐342‐Rev 00 Japan AFM Registration Company code : 784892000 and manufacturing Under Registration site code: 784892001
• Planning for US FDA/PMDA shortly.
Contributing to Good Health for Good Life CERTIFICATIONS
Contributing to Good Health for Good Life CERTIFICATIONS
Contributing to Good Health for Good Life PRODUCT LIST
Available Status On
THERAPEUTIC PRODUCTS
CATEGORY CEP JDMF JDMF DMF DMF TECH EDMF/ EDMF/ TDMF/ TDMF/ KDMF/ KDMF/ PACK US DMF BRAZIL PATENT MEXICO
Alogliptin* Antidiabetic 2016 2016 2016 2016 2016 2016 Apremilast* Anti-Inflammatory 2016 2016 2016 2016 2016 2016 Azithromycin Dihydrate Macrolides - Agomelatine Form II Agomelatine Form Antidepressant India 2016 2016 2016 2016 2016 Co Crystal* Aprepitant Form I And Form II Anti-Emetic Bisoprolol Hemifumarate Anti Hypertensive (CEP NO..2013-342) Bazedoxifene Acetate Form A&B Selective Estrogen Receptor Modulator 2016 2016 2016 2016 2016 Beraprost* Pulmonary 2016 2016 2016 2016 2016 2016 Hypertension Brexpiprazole* Antidepressant 2016 2016 2016 2016 2016 2016 Chloramphenicol Base Anti Bacterial ---- - &Palmitate Cinacalcet Hcl Form I Calcimimetic PCT/India Empagliflozin* Antidiabetic 2016 2016 2016 2016 2016 2016
Dabigrtran Etexilate Mesylate
Dapagliflozin Antidiabetic 2016 2016 2016 2016 2016 2016
Erythromycin Base- CEP NO RO-CEP 2009-267 Erythromycin Ethyl Succinate Macrolides (CEP NO ..2015-211) Erythromycin Stearate (CEP NO.. 2015-225) Edoxaban* Anticoagulant 2016 2016 2016 2016 2016 2016 Fluvoxamine Maleate Antidepressant Linagliptin Antidiabetic 2016 2016 2016 2016 2016 2016 Macitentan* Antihypertensive 2016 2016 2016 2016 2016 2016 Mirabegron Adrenergic 2016 2016 2016 2016 2016 2016 Receptor Rivaroxaban Anticoagulant 2016 2016 2016 2016 2016 2016 India Teneligliptin* Antidiabetic 2016 2016 2016 2016 2016 2016 Remarks:* Under development/evaluation. Available. All transactions are carried out in conformity with patent laws applicable in the user country, responsibility with respect to third parties rightsin a specific country lies exclusively with the user. The above products are offered as per BP/EP/USP/JP and FP and as per customer’s in‐house specifications. Also available in Microfine.
Email :[email protected] & Web site: www.mehtaapi.com INTERMEDIATE LIST
NAME OF INTERMEDIATES CAS NO END PRODUCT
7-Methoxy-1-naphthylacetonitrile 138113-08-3 Agomelatine
2-[(6-Chloro-3,4-dihydro-3-Methyl-2,4-dioxo-1(2h)-pyriMidinyl)Methyl]benzonitrile 865758-96-9* Alogliptin
Tert-butyl (R)-piperidin-3-ylcarbamate/(R)-piperidin-3-amine dihydrochloride 334618-23-4*
N-Methylcarbonyl-2-Chloroacetamidrazone 155742-64-6 Aprepitant
(2R,3S)-2-[(1R)-1-[3,5-is(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholine 171482-05-6 hydrochloride 3-AcetaMidophthalic anhydride 6296-53-3 Apremilast
Azithromycin Amine 76801-85-9 Azithromycin Dihydrate
3-Methyl-5(phenylmethoxy)-2-[4-(phenylmethoxy)phenyl]-1H-indole 198479-63-9 Bazedoxifene
1-(2-(4-(Chloromethyl)phenoxy)ethyl)azepane HCL 223251-25-0
1-[4-(2-Azepan-1-yl-ethoxy)-benzyl]-5-benzyloxy-2-(4-benzyloxy -phenyl)-3-methyl- 198480-21-6 1h-indole 2-{3-[5-(4-Fluoro-phenyl)-thiophen-2-ylmethyl]-4-methyl-phenyl}-3,4,5-tris- 1132832-76-8 Canagliflozin trimethylsilanyloxy-6-trimethylsilanyloxymethyl-tetrahydro-pyran-2-ol 2,3,4,6-Tetrakis-O-trimethylsilyl-D-gluconolactone 32384-65-9 Canagliflozin/Dapagliflozin
3-(3'-Trifluoromethylphenyl)propanol 78573-45-2 Cinacalcet
3-[(3-Amino-4-methylaminobenzoyl)pyridine-2-ylamino]propionic acid with ethyl ester 212322-56-0 Dabigatran
2,3,4,6-Tetra-O-pivaloyl-alpha-D-glucopyranosyl bromide 81058-27-7 Dapagliflozin
1-(1,2,3,6-Tetrahydro-4-pyridyl)-2-Benzimidazolione 2147-83-3 Droperidol tert-Butyl [(1R,2S,5S)-2-amino-5-[(dimethylamino)carbonyl]cyclohexyl]carbamate 1210348-34-7 Edoxaban oxalate 5-Methoxy -1-[4-(trifluromethyl)phenyl]-1-pentan oxime 61747-22-6 Fluvoxamine Maleate
1,3-Dihydro-3-(3-iodopropyl)-7,8-dimethoxy-2H-3-benzazepin-2-one 148870‐57‐9
Evabradine (Z)-3-(3-chloropropyl)-7,8-diethyl-1H-benzo[d] azepin-2 (3H)-one 85175-59-3
NAME OF INTERMEDIATES CAS NO END PRODUCT
(R)-N-benzyl-2-t-butoxycarbonylamino-3-methoxy propanamide 880468-89-3 Lacosamide
(R)-N-benzyl-2-t-butoxycarbonylamino-3-hydroxy propanamide 1253790-58-7
1-{(4-methyl-quianazolin-2yl)methyl}-3-methyl-7-(2-butyn-1-yl)-8-bromo-xanthine 853029-57-9 Linagliptin
Tert-butyl (R)-piperidin-3-ylcarbamate/(R)-piperidin-3-amine dihydrochloride 334618-23-4
Erythromycin Oxime 13127-18-19 Macrolide
(1R)-2-{[2-(4-aminophenyl)ethyl]amino}-1-phenylethanol HCL 521284-22-0 Mirabegron
S-1-decyn-O-tert dimethyl silyl-2-yl-5-ol Prostaglandin
2-[[(5S)-2-Oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-5-oxazolidinyl]methyl]-1H- 446292-08-6 Rivaroxaban isoindole-1,3(2H)-dione 4-{4-[(5S)-5-(aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one 898543-06-1 Hydrochloride 5-Bromo-2-(2-methyl-2H-tetrazol-5-yl)pyridine 380380-64-3 Tedizolid
1-(3-Methyl-1-phenyl-5-pyrazolyl)piperazine 401566-79-8 Tenaligliptin
2S)-4-oxo-2-(1,3-thiazolidin-3-ylcarbonyl)pyrrolidine-1-carboxylate 401564-36-1
1-Naphthalenesulfonic acid, (diethoxyphosphinyl)methyl ester 145980-33-2 Tenofovir
Remarks:* Under development/evaluation. Available.
All transactions are carried out in conformity with patent laws applicable in the user country, responsibility with respect to third parties rightsin a specific country lies exclusively with the user. The above products are offered as per BP/EP/USP/JP and FP and as per customer’s in‐house specifications. Also available in Microfine.
Email :[email protected] & Web site: www.mehtaapi.com
MARKET EXISTENCE
Contributing to Good Health for Good Life THANK YOU MEHTA API looks forward to work together for enriching lives globally…
Contact at HO :
Mehta API P. Ltd. , 203, Centre Point, 2nd Floor, Near Hotel Kohinoor, J.B.Nagar, Andheri-Kurla Road, Andheri (East), Mumbai - 400059 Board No: 91-22-28395643/45 Fax no : 91-22-28395644 Email Id: [email protected] & [email protected]
Web: www.mehtaapi.com
Contributing to Good Health for Good Life