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Pharmaceutical Manufacturing
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Enaltec has established world class infrastructure for manufacturing APIs complying with the requirements of Regulated & semi regulated markets. All our labs are GLP compliant and our manufacturing plants are cGMP approved.

We have manufacturing capabilities ranging from gm level to multiple tonne lots. We are capable of doing a wide range of reactions including high pressure hydrogenations and nBuLi reactions on a large scale.

We have two multipurpose small to large volume plants with volumes ranging from 50 ltrs to 4000 ltrs capacity. With one focusing for less regulated and semi regulated markets and other complying to US & EU regulatory requirements.

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The Infrastructure

  • Fully equipped R&D center - location Ambernath

  • US FDA approvable - Pilot Plant - location Ambernath

  • US FDA approvable - Kilo lab plant - location Ambernath

  • WHO GMP approvable large volume plant - location Dombivali

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Multipurpose Plant 1: Location DOMBIVALI (for less & semi regulated markets)

  • WHO GMP APPROVABLE PLANT

  • 220 Sq mt (11 room) clear room area with bonded store room

  • Individual AHU with 100,000 class

  • EQUIPPED WITH 20,000 LTRS WORKING CAPACITY

  • 15 REACTORS - 9 SSR'S AND 6 GLR (200 LTRS - 4 KL CAPACITY)

  • 1 Cyrogenic Reactor with 500 ltrs capacity

  • 1 HYDROGENATOR - 35 KGS Working pressure

  • 6 CENTRIFUGES - 1 - 36" AND 5 - 48" (SS)

  • 4 DRIERS - 1 TD - 96 TRAYS AND 1 TD - 48 TRAYS, 2 FD - 60 KGS

  • 1 MULTIMILL - 1000 LTRS CAPACITY

  • RPVD - 250 LITRES

  • PILOT PLANT - with 4 SS reactors of 150 ltrs to 500 ltrs capacity, and 1 GLR of 250 litres and 1 glass assembly of 50 litres capacity

  • FULL EQUIPPED Q.C LAB with key instruments as HPLC, GC, UV spectrometer, Water Purification systems etc.

  • PROCESS DEVELOPMENT LAB - of 1000 sq ft and reaction assembly ranging from 0.25 ltrs to 20 ltrs.

Pharma Manufacturing Facility
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Manufacturing Facility
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Multipurpose Plant 2: Ambernath - US FDA & EU approvable

Our USFDA approvable pilot plant spread over an area of 10,000 sq ft is best suited for manufacturing 2 products simultaneously in capacity of gms levels to few hundred kgs level (per month) for API's and advanced intermediates. A fully qualified HVAC system including full control of temperature, humidity and room pressure ensures the right environment for quality manufacturing.

  • 2 stand alone GMP suites with US FDA approvable with world class kilo labs

  • We are capable of doing a wide range of reactions from cryogenic to pyrophoric reactions on a plant scale

  • Total 4 Reactors - Both SS & GLR

  • 1 Glass Line Reactors : 1000 Ltrs Capacity

  • 3 SS Reactors - from 500 Ltrs to 2000 Ltrs Capacitys

  • Clean Room Area

  • Kilo lab plant with capacity of 10 kgs - 50 and 100 lits glass assemblies - US FDA approvable

Pharma Manufacturing Plant
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API Manufacturing Plant
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