Formulation Development
Enem Nostrum’s 3000 sq. feet Formulation Research &development laboratory is based at Andheri, Mumbai located at less than 10 minute drive from Mumbai International Airport.
Enem Nostrum provides robust Pharamceutical Formulation Development Services to our clients. Our two decades of experience in pharmaceutical development along with modern Research and Development laboratory are ideally suited to meet all of your formulation development needs. Enem Nostrum has expertise in development of the following dosage forms,
Our Formulation laboratory is fully equipped with
Enem Nostrum has state of art formulation development facility with modern equipment and experienced formulation scientists. Enem Nostrum is committed to provide Pharmaceutical products and Services of highest Quality standards through continual improvement and in compliance to the applicable regulatory requirements to maximize efficiency, save resources and increase customer satisfaction Quality by Design (QbD) approach is an integral part of the product development. All the systems are supported with detailed standard operating procedures and specific protocols, which are authorized for use by Quality Assurance department..Enem advantages includes development of high quality drug products within short period of time maintaining the client confidentiality as well as Protection of intellectual property. Enem’s quick access to global market, has great advantage for our clients. Enem provides support not only during the development of the formulations but has expertise to extend its support during scale up and technology transfer, product submissions and commercial manufacturing. Enem has already developed several no-infringing ,bioequivalent products for its clients which were submitted to USFDA and has reveived approvals and subsequently commercialized for US market.
Key Equipment and Instruments:
Our laboratory is well-equipped to handle following processes
At Enem Nostrum our new product development program generally includes literature surveys, pre-formulation studies, compatibility studies, analytical method development and validation, formulation development and optimization, formal stability studies, and manufacturing process development according to international Guidelines.
0.5 quart to 16 quart (about 0.5 Liters to 15 Liters working capacity) V-Blenders equipped with high-speed intensifier bars (or lump breakers) along with spray mechanism for liquid addition.
Roller compactor with an Output (Kgs / Hr): 2 to 5. Improves powder flow properties, avoid wet granulation induced degradation, improve product stability, prevent segregation and reduce bulk volume.
Rapid Mixer Granulator capacity: 10 Liters
Sejong GRC-Series 15 Station Pilot Press
Bilayer Rotary tablet Press
9 stations for production of double-layer and mono layer tablets
Autocoaters, Available in Pan sizes with capacities: 200 g to 5 Kg
Mack Pharma Tech Stability chambers
Technology / Expertise
Work done at Enem Nostrum has resulted in several patents
US 6946146 B2 | Coating For A Sustained Release Pharmaceutical Composition |
US 8545882 B2 | Control Release Formulation Containing A Hydrophobic Material As The Sustained Release Agent |
US 7052706 B2 | Control Release Formulation Containing A Hydrophobic Material As The Sustained Release Agent |
US 8507000 B2 | Controlled Release Formulation Of Erythromycin Derivatives |
US 6437000 B1 | Controlled Release Oral Dosage For Suitable For Oral Administration |
US6475493B1 | Controlled Release Pellet Formulation |
US6635680B2 | Controlled Release Pellet Formulation |
US6638522B1 | Microemulsion Concentrate Composition Of Cyclosporin |
US7897179B2 | Pharmaceutical Composition Containing Water Soluble Drug |
US8906419B2 | Pharmaceutical Composition Containing Water Soluble Drug |
US7179486B1 | Process For Preparing Sustained Release Tablets |
US6436430B1 | Self-emulsifying Compositions For Drugs Poorly Soluble In Water |
US6416786B1 | Sustained Release Tablet Containing Hydrocolloid And Cellulose Ether |
Andheri Office (Corporate Office and Research Centre)
201-204, Gayatri Commercial Complex,
Behind Mittal Industrial Estate, Marol,
Andheri (E), Mumbai - 4000 59. INDIA.
+91 22 4040 5000
Govandi Office (BA/BE Center)
Plot No 35, Ancilliary Industrial Plots,
Near BMC 'M' ward office,
Govandi (West) Mumbai 400 043, India
+91 22 2548 8231
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