Manufacturing Facilities - Glenmark Pharmaceuticals

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Manufacturing Facilities

Manufacturing Facilities Delivering high quality products across the globe

Monroe, North Carolina, USA

Monroe, US

Spread across 105,000 sq. ft., this facility is dedicated to the manufacturing of sterile injectable products (vial and pre-filled syringes).

Estimated investment is approximately USD 100 M over five years.

Regulatory Approvals
US-FDA

Annual Capacity
Oral solids: 300 – 400 Mn tablets and capsules
Injectable: 20 – 25 M vials and pre-filled syringes
Inhalation: 25 – 30 mn ampules

Markets
USA

Goa, India

The facility commenced operations in 2004.
Three manufacturing facilities for production of:
Oral solid dosages (OSD): 4800 Mn Tablets and 1200 Mn Capsules
Semi-solids: 32 Mn Tubes / Sachets
Hormone: 720 Mn Tablets
ISO 14001: 2015, ISO 45001: 2018

Regulatory Approvals
US-FDA
MCC South Africa
WHO – GMP
ANVISA Brazil
MHRA UK
RU – GMP Russia
SUKL – CZ

Annual Capacity
Oral solid dosages (OSD): 4800 Mn Tablets and 1200 Mn Capsules
Mn tablets and 100 Mn capsules
Semi-solids: 32 Mn Tubes / Sachets
Hormone: 720 Mn Tablets

Markets
North America, Western Europe

Baddi, India

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Baddi, India

This state-of-the-art manufacturing facility commenced operations in 2005.
The facility caters to the production of oral solids and liquid orals, external preparations like lotions, creams and respiratory segment products like Nasal spray, metered dose inhalers (MDI) and Dry powder inhalers (DPI).
ISO 14001: 2015 approved, ISO 45001: 2018

Regulatory Approvals
WHO GMP
US FDA
ATOVAQUONE
ANVISA BRAZIL
UK-MHRA (EU)
SUKL- CZECH REPUBLIC
UKRAINIAN-GMP
MCC
MOH RUSSIA
ZAZIBONA
NAMIBIA MEDICINES REGULATORY COUNCIL NAMIBIA
ZIMBABWE
TFDA TANZANIA
ZANZIBAR
GULF CO-OPERATION COUNCIL (GCC)
RU-GMP
MEXICO (COFEPRIS)
TGA – AUSTRALIA

Annual Capacity
Oral solids: 900 Mn tablets / capsules
Liquids: 40 Mn bottles
Semisolids: 9 Mn Tubes/Bottles
Respiratory segment: 25 Mn Units

Markets
USA, Europe, India, Brazil, Ukraine, Russia, Argentina & Mexico, Other semi-regulated markets for specific dosage forms

Nalagarh, India

The facility commenced operations in 2009.
The plant has three main sections for manufacturing Liquid, Ointments / Creams and lotions.
ISO 14001: 2004 approved, ISO 22716 : GMP for Cosmetics

Regulatory Approvals
ANVISA Brazil
NDA – Uganda, TFDA Tanzania
FDA – Philippines, NMRC Namibia
NMPB Sudan, PPB Kenya
WHO – GMP , Local FDA
ISO 45001:2018, 14001: 2015

Annual Capacity
Oral liquids: 64. million bottles
Ointments and creams: 64 million units
Lotions: 32 million bottles

Markets
India, Asia, Africa

Sikkim, India

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Sikkim, India

Established in 2012, the facility is focused on manufacturing oral solid dosages.
ISO 14001: 2015 Approved, ISO 45001: 2018 Approved

Regulatory Approvals
Local FDA

Annual Capacity
Oral Solid dosages : 2000 million tablets & 50 million capsules

Markets
India

Nashik, India

Glenmark’s first manufacturing unit, it began operations in 1983.
The facility manufactures products catering to demand in oral solids, liquid orals, external creams and powder shampoo.
ISO 14001: 2015, OHSAS 45001: 2018

Regulatory Approvals
WHO – GMP
ANVISA (Brazil)
NDA – Uganda
MOH – Nigeria
TFDA – Tanzania
MOH – Ethiopia
MOH – Congo
UKRAINIAN -GMP
MCC – South Africa
MOH – Oman
MOH – Ukraine
INVIMA – Columbia
SAUMP-Ukraine
RU – GMP Russia

Annual Capacity
Oral solids: 222 Mn tablets / capsules per year
Oral Liquids: 15.6 Mn bottles per year
External preparations: 48 Mn units per year
Powder Shampoo: 2.4 Mn units per year

Markets
Asia, India, Africa, CIS / Russia, Latin America

Indore, India

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Indore, India

The Indore facility initiated operations in May 2009.
ISO 14001: 2015, ISO 45001: 2018 approved

Click to view the Biomedical waste generation data 2020-21

Regulatory Approvals
US-FDA
UK MHRA
WHO – GMP
SUKL – CZ

Annual Capacity
Oral solid dosages: 1490 Mn tablets
Immuno Suppressant Block:Capsules – 42 Mn
Ointment & Creams – 80 MT

Markets
North America, Europe

Buenos Aires, Argentina

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Buenos Aires, Argentina

The Glenmark manufacturing site at Buenos Aires, Argentina is focused on manufacturing of Oncology Injectables.

The plant is spread across 30,000 sq. ft. and it serves as a global hub for manufacturing Lyophilized and Liquid Injectables used in oncology therapies.
ISO 14001: 2015 approved , ISO 45001: 2018 approved

Regulatory Approvals
ANMAT Local MOH
ANVISA Brazil
INVIMA Colombia
COFEPRIS Mexico
SFDA Saudi Arabia
MCC South Africa
GCC UAE – KSA
DRAP Pakistan
Ukrainian GMP
Sudan GMP
Syrian Arab Republic GMP
CHMP Kenya
SUKL Czech Republic

Annual Capacity
Injectables:
Liquid – 1Mn Vials
Lyophilized – 1Mn Vials

Markets
Brazil, Mexico, Argentina, Vietnam, Indonesia, Caribbean countries,
Other Latin American, Middle East and African countries

Vysoke Myto, Czech Republic

This manufacturing facility, formerly known as Medicamenta, was set-up in 1952 and was acquired by Glenmark in 2007. Presently the facility manufactures solid-orals.
OHSAS certification, ISO 14001:2015, ISO 45001:2018 a ISO 50001:2018

Regulatory Approvals
Manufacturing licence for medicinal products (Issued by SUKL)
Distribution licence for medicinal products (Issued by SUKL)
Certificate of GMP Compliance of Manufacturer (Issued by SUKL)

Annual Capacity
Oral solid dosages: 200 Mn tablets

Markets
Czech Republic, Slovakia, Poland, Great Britain, Germany, Denmark, Spain, Finland, Sweden, Netherland, Portugal

Aurangabad, India

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Aurangabad, India

Glenmark’s Aurangabad facility initiated operations in April 2012. Aurangabad site is focused in the manufacturing of Formulations (OSD, Inhaler & Foam). This plant is spread over 30 acres and it serves to both domestic and international markets.
ISO 14001: 2015 approved, ISO 45001: 2018 approved

Regulatory Approvals
US-FDA
SUKL
WHO – GMP
ANMAT
ANVISA
INVIMA
NDA-Uganda
State Institute Of Drugs & Good Practices-Russia

Annual Capacity
Tablet : 22 Mn
MDI : 11 Mn
Nasal Spray: 8.4 Mn
Topical Foam : 0.6 Mn

Markets
ROW, Domestic, US, Brazil

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STATE-OF-THE-ART INFRASTRUCTURE
CUTTING EDGE PROCESSES