Vertically integrated global pharmaceutical company

Umedica
Laboratories
Supply &
Amoli Marketing
Umedica
Organics
FDF Plant
R&D
Umedica
R&D
Amoli
Organics o Founded in 1982 by Mr. Umed Doshi
API
o Business – Formulation (Only international)
o Business in more than 71 countries.
o Founded in 1991 by Mr. Manish Doshi
o Corporate office in Mumbai , India
o Business – API (Domestic and International)
o Subsidiary Netherlands
o Export to more than 85 countries and have
more than 550 satisfied customers globally.
o Corporate Office in Mumbai , India
The Journey

2019
2018 Commercialisation
2017 ANDA Approval in
UAE
EU-GMP
Approval Commercialisation Europe
2015
in US Australia
US FDA
2010 plant
MA approval in
approval
R&D Centre EU
started
Netherlands
1992 Subsidiary
established
Commercialisation
1991
1982 - 90 in
1982 Amoli Asia
Contract
Established (API Division) Africa
Manufacturing
for local Established LATAM
FDF Plant companies
Operational
Amoli API Manufacturing Plants

• Location: • Location:
Vapi, Gujarat, India Vadodra, Gujarat, India
• Accreditations: • Accreditations:
o USFDA – Inspected & approved (6 US-DMFs) o USFDA – Inspected & approved (14 US-DMFs)
o EU-GMP/ EDQM – Inspected & approved
o EU-GMP/ EDQM – Inspected & approved
o Japan – Accreditation of Foreign Manufacturer (AFM)
available for the plant o Brazil – Inspected and approved by ANVISA
o Mexico - Inspected and approved by COFEPRIS
o Mexico - Inspected and approved by COFEPRIS
o Australia – Approved by TGA
o MIT Russia – Inspected and approved. o MIT Russia – Inspected and approved.
Umedica Formulation Manufacturing Plant

• Location:
Vapi, Gujarat, India

• Area:
Built up area of 11,000 sq. m
• Dosage forms:
• Oral Solids
Tablets, Capsules, Dry Syrups
• Injectables
Liquid Injections, Dry Power Injections
• Therapeutic areas:
Antibiotics (non-beta lactams), NSAIDs, analgesics,
antifungal, antiviral, anti-malarial, antituberculosis,
antihistaminic, psychotropic, diuretics,
antihypertensive, Antihyperlipidemic, drugs for erectile
dysfunction, multivitamins etc.
Accreditations
• Inspected and approved by USFDA
• Inspected in October, 2015. EIR received.
• Inspected in May, 2017. EIR received.
• Inspected in January, 2018. EIR received.

• EU GMP approval 2017

• Republic of Croatia, Agency for Medicinal Products
and Medical Devices

• Facility registered with UAE MoH.

• Received TGA Clearance from Australia

• Health Canada approval in 2019

Our Research and Development Centre
Amoli R&D Center at Vadodara, Gujarat
 Well equipped 2 synthetic labs, 2 analytical lab and a Pilot plant with SS and GL reactors ( 250
L to 1200 L) spread over 12,000 sq.ft.
 Has a talented pool of 80 scientists including organic / analytical chemists
 Taken aggressive target to work on more than 6-8 molecules each year
 Developed 21 molecules for regulated markets in the last 3 years
 19 molecules under development for regulated markets being filed in the next 2 years

Umedica R&D Center at Turbhe, Navi Mumbai

 Well Equipped R&D center with well qualified, dedicated & experienced team of more than 90
scientists.
 Approved by the Ministry of Science &Technology, Government of India
 Built – up area of 19,000 sq. ft.
 Developed 13 products for regulated markets in the last 3 years
 15 products under development for regulated markets being filed in the next 2 years
Formulation Development Capabilities
Tablets Oral Liquids
• Immediate Release • Solutions
• Modified Release • Suspensions
• Orally Disintegrating (ODT) • Emulsions
• Multi-Layer Tablets • Syrups
• Powder for Suspension (Sachets & Bottles)

Capsules Topical Dosage Forms

• Powder Blends • Gels
• Multi-Particulates (Beads & Granules) • Creams
• Immediate Release • Ointments
• Modified Release • Lotions
• Tablet in Capsule

Injectables
* Liquid injections filled in Ampoules & Vials
• Dry powders for injections
Global Footprint
Umedica has presence in more than 71 countries globally including regulated markets of US, Europe and Australia

Our Offices
Umedica Headquarters
Umedica Netherlands BV
 Our Global Product Status

• 10 ANDA’s filed in US. • 7 products filed for • 4 product under evaluation • 700 live registrations in
Marketing Authorization in in TGA. emerging markets of Asia,
• Received ANDA of
Chlorthalidone, Europe. Africa and Latin America
• 3 OTC products
Rosuvastatin, Olmesartan & • Received Marketing
Olmesartan + HCTZ. Authorization of Sildenafil, • 1 Prescription product
• 5 ANDAs expected in 2019. Rosuvastatin, Tadalafil,
Olmesartan + HCTZ &
• 2 ANDS filed in Canada Solifenacin
• 5 ANDS to be filed by end of
2019.

USA & AUSTRALIA ROW

EUROPE
CANADA
 Our Global Business Model
To stay abreast with global markets, Umedica offers a flexible business model to its partners for strategically
adapting to the local requirements.

Distribution Out-Licensing Contract Development/ Technology –

Supply developed Licensing developed
Manufacturing Co-Development transfer with API
finished products to dossier / approved MA Leveraging Umedica’s Open platform Technology transfer of
local partners at a to local partners. manufacturing collaboration to develop Umedica’s products to
competitive cost. capabilities in products jointly by local manufacturing
manufacturing partners leveraging our partners.
products. technological know how
and capabilities across Supply API & provide
the drug life cycle. support for easy
execution of the
technology at partner’s
site.
Partner of Choice
o More than 35 years experience in pharmaceutical manufacturing with reliable and
solid reputation as a high quality supplier.

o A leading provider of fully integrated services – API & Formulation development and
manufacturing

o End to end service

o Seamless project management collaboration for rapid advancement from
development to commercialisation.

o Dedicated team of Experts

o For Development, Technology Transfer, Manufacturing, QC (Chemical and
Microbiological), Regulatory and QA, with the support of the Logistic, Planning
and Purchasing.

o Collaborative & cost effective model

o With the strong base of trust, transparency, focused on strong long term
partnerships
o Dedicated to meet your requirements of time-to market with highest quality
finished products in a cost-effective model
 Thank you

Address: 302, 3rd Floor, Dalamal House, Jamnalal Bajaj Road, Nariman Point, Mumbai- 400021
: (+91-22) 62455027
: http://www.umedicalabs.com/
: exports@umedicalabs.com