Recent Updates
Regulatory Approvals
Product Development
New GMP Facility
Hormonal Block
Completed the dedicated block for manufacturing hormonal products with the following features:
Facility Audits
The company’s manufacturing facility has been audited by seven EU/US/Ukraine/Indian customers during the quarter and confirmed GMP compliance.
Kazakhstan GMP audit completed in April 2016; awaiting approval.
Market Development
Business Development department has successfully concluded new contracts with 15 customers from Europe and USA under each of the company’s business segments namely Out-licensing of its products, Contract Development, Contract Manufacturing and Tech Transfer (& Submission Batch manufacturing) of customer’s products.
Change of Name
The company has successfully changed its name from ‘Optimus Generics Limited’ to ‘Evertogen Lifesciences Limited’.
Our new name reflects our unique identity and positioning in the market place. We also wish to confirm that, with this change, there is no change in the company’s constitution, ownership, management and Board of Directors, and our commitment & responsibility towards our stakeholders remain the same as they are.
- Facility Approvals
UK MHRA inspected for renewal of GMP facility and approved for three years - Product Approvals
- Market Authorization for Amlodipine, Telmisartan, Cetirizine,Levocetirizine, Carbidopa+Levodopa and Raloxifen tablets granted to customers in various countries of EU
- Received approvals for Telmisartan & Cetirizine in Canada and started commercial supplies
- Received approvals for few other customer’ products in Australia
Product Development
- Successful bio-equivalent results obtained for the products Carbidopa+Levodopa, Telmisartan+Hydrochlorothiazide, Telmisartan+Amlodipine Tablets
- Successfully completed formulation development of Dipyridamole 200mg ER capsules, Aspirin/Dipyridalome 25/200mg ER, Clopidogrel/Aspirin and Carbidopa/Levodopa ER, and biostudies are expected to be completed by October 2016
- Successfully completed development for customer products in Anticoagulant, Multiple Sclerosis, Antimicrobials and Diabetics Therapeutic category for regulatory filing in EU market, in 2016
New GMP Facility
Hormonal Block
Completed the dedicated block for manufacturing hormonal products with the following features:
- This facility is equipped with equipment for hormonal manufacturing, with independent AHU
- This is an ISO Class 8 facility
- Environmental conditions: Temperature – NMT 25 ° C; Relative humidity – NMT 60%
- Use of pressure suits for personnel safety
- Exit from block with Mist + air shower with 0.3 micron filtered air
- The minimum batch size is 20 kg and the maximum batch size is 350 kg.
Facility Audits
The company’s manufacturing facility has been audited by seven EU/US/Ukraine/Indian customers during the quarter and confirmed GMP compliance.
Kazakhstan GMP audit completed in April 2016; awaiting approval.
Market Development
Business Development department has successfully concluded new contracts with 15 customers from Europe and USA under each of the company’s business segments namely Out-licensing of its products, Contract Development, Contract Manufacturing and Tech Transfer (& Submission Batch manufacturing) of customer’s products.
Change of Name
The company has successfully changed its name from ‘Optimus Generics Limited’ to ‘Evertogen Lifesciences Limited’.
Our new name reflects our unique identity and positioning in the market place. We also wish to confirm that, with this change, there is no change in the company’s constitution, ownership, management and Board of Directors, and our commitment & responsibility towards our stakeholders remain the same as they are.