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,MOHYemen, 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.
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.
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.