We never compromise
on quality.


Manufacturing Site #1 (Ambernath, India)

Rubicon Research's world-class Ambernath plant is focused on producing pharmaceutical products (Rx as well as over the counter), and supports scale up and commercialization in a range of oral solids.

Our manufacturing facility in Ambernath, Maharashtra, India is 14,250m² for manufacturing of oral solid dosages and more recently, for manufacturing of unit-dose, bi-dose, and multi-dose nasal sprays. The facility is US FDA approved.

Ambernath Plant

Product Capabilities

Tablets Capsules Granules Pellets Powders Tablet in Capsules
Tablets
Capsules
Granules
Pellets
Powders
Tablet in Capsules
Unit Year of commencement of operations Dosage Forms Major Accreditations/Certifications and Certifying Authorities
Ambernath, Maharashtra, India 2009 Oral solid dosages: Tablets, capsules, dispersible tablets, powders, and hard gelatin capsules
  • US FDA
  • MHRA UK
  • Health Canada
  • Food and Drugs Administration, Maharashtra (WHO-GMP accreditation)
  • TGA Australia
  • Ministry of Health, Cambodia
2024 Nasal dosages: sprays and drug device combinations
  • US FDA
Unit
Ambernath, Maharashtra, India
Year of operations
2009
Dosage Forms
Oral solid dosages: Tablets, capsules, dispersible tablets, powders, and hard gelatin capsules
Accreditations
  • US FDA
  • MHRA UK
  • Health Canada
  • Food and Drugs Administration, Maharashtra (WHO-GMP accreditation)
  • TGA Australia
  • Ministry of Health, Cambodia
Unit
Ambernath, Maharashtra, India
Year of operations
2024
Dosage Forms
Nasal dosages: sprays and drug device combinations
Accreditations
  • US FDA

Our manufacturing facility in Ambernath has separate filling lines for unit-dose, bi-dose and multi-dose nasal sprays. This enables us to progress a nasal spray product from its conception to development and up until its commercial supply. We currently have one approved product which is a multi-dose nasal spray that utilizes a drug-device combination.

Manufacturing Site #2 (Satara, India)

Satara Manufacturing Site

Our other manufacturing facility in Satara, Maharashtra, India is 4,050 m² for manufacturing of oral liquid dosages. The Satara unit is accredited and certified by US FDA, MHRA UK, TGA Australia and Government ministry of Health, Vietnam.

Our manufacturing facilities at Ambernath and Satara in India are both US FDA approved.

Unit Year of commencement of operations Dosage Forms Major Accreditations/Certifications and Certifying Authorities
Satara, Maharashtra, India 2021 (year of acquisition by the Company) Oral liquids: Oral syrups, suspensions, and solutions
  • US FDA
  • MHRA UK
  • TGA Australia
  • Government ministry of Health, Vietnam
Unit
Satara, Maharashtra, India
Year of operations
2021 (year of acquisition by the Company)
Dosage Forms
Oral liquids: Oral syrups, suspensions, and solutions
Accreditations
  • US FDA
  • MHRA UK
  • TGA Australia
  • Government ministry of Health, Vietnam

To request for our equipment list, drop us an email at bd@rubicon.co.in