Formulations

Formulations

Covers the needs of International markets with a range of more than 100 dosage forms including Tablets, Capsules, Dry Powder, Suspension and Injectables. Many of the APIs are made in house, thereby providing a competitive edge for both branded and generic formulations.

Plant Accreditations For Khopoli Plant :

• Conformation to the Good Manufacturing Practices of International Standards.
• Approved by 11 countries including TGA Australia,MCC South Africa, MHRA UK,FMHACA Ethiopia, PPB Kenya,MOH Oman,MOH Yemen, NDA Uganda, MOH Ivory Coast
• GMP Certification by FDA, Government of Maharashtra
• WHO GMP Certification by CDSCO, Government of India
• More than 428 Product approvals in 46 countries including 10 registrations / product approvals (Amlodipine Tabs, Omeprazole Caps, Azithromycin Caps, Albendazole Tabs, Flucloxacillin, Erythromycin Tabs, Ibuprofen Tabs, Ceftriaxone Inj. & Amoxycillin range) in South Africa.

Manufacturing Facilities

• The facility is located at Khopoli, Raigad District, Maharashtra.
• The manufacturing facility has built up area of 11,432 sq. mtrs. on a plot of 8 Acres.
• Dedicated manufacturing plants for:
  
  • Penicillin based Finished Dosage Forms with an annual capacity of 1500 million Capsules, 20 million bottles Dry Syrup and 500 million Tablets.
  • Non-Penicillin based Finished Dosage Forms with an annual capacity of 2000 million Tablets (Uncoated), 1000 million Tablets (Coated) and 500 million Capsules.

Formulations Development

• Developing Products/formulations matching Reference/Innovators products for the regulated markets.
• Generating validation documents for quicker Site Variations in critical markets where the lead time for variation approval is longer.
• Focus on Newer and Unique dosage forms like, SR Tabs, Mouth Dissolving Tabs as a tool to add value to the current product portfolio.
• Developing Amoxy Clauv to give strategic advantage to the current Amoxy customer base.
• formulations / Packaging development initiatives.