USV Limited

We have a pipeline of 8 biosimilar products (produced by recombinant biotechnology in E.Coli) at various stages of development, including 2 in confirmatory clinical trials and 3 in pre-clinical toxicity studies.

Somatropin For Injection Ph.Eur

• PCT’s have been filed and National Phase filings are under progress in various countries.
• Non-solvent (aqueous) based drug substance purification process.
• Pre-clinical toxicity studies have been successfully completed as per schedule Y of Drugs & Cosmetics Act, India.
• Safety & Efficacy clinical trial (phase-III) is in progress.

Teriperatide Injection

• Drug: Biologically active N-terminal portion of Parathyroid Hormone.
• IN and PCT applications have been filed.
• Non-infringing Cloning, Fermentation and Purification technology.
• Pre-clinical toxicity studies have been successfully completed as per schedule Y of Drugs & Cosmetics Act, India.

Platelet Derived Growth Factor (PDGF-BB) Gel

• Drug Class: Growth Factor.
• INN: Becaplermin.
• Novel cloning, Fermentation and purification technology.
• Developed novel gel formulation; Indian patent is filed.
• Pre-clinical toxicity studies have been successfully completed as per schedule Y of Drugs & Cosmetics Act, India.

Filgrastim Injection (G-CSF)

• Drug Class: Colony stimulating factor.
• Non-infringing Cloning, Fermentation and Purification technology.
• Non-solvent (aqueous) based drug substance purification process.
• PCT application has been filed.
• Drug Substance is complying with Ph.Eur monograph specifications.
• Pre-clinical toxicity studies as per EMEA Biosimilar guideline for Filgrastim are in progress using Neupogen® of Amgen, Germany as reference product.

For all the above products, the cell banks (MCB & WCB) are prepared and characterized as per ICH Q5B & Q5D guidelines. And also both the Drug substance and drug product are completely characterized as per ICH Q6B guideline and compared with the reference medicinal products.

Our injectable portfolio includes small molecules, peptides & recombinant proteins. These products would be manufactured in our ‘Fill & Finish’ sterile plant.

• Eptifibatide Injection 20mg/10 ml & 75mg/100 ml (Anti-Thrombotic Agent)
• Bivalirudin Injection 250 mg lyophilized powder in 10ml vial (Anti-Thrombotic Agent)
• Dolasetron Mesylate Injection 20mg/ml (5ml in 10ml vial & 0.625ml in 2 ml vial) (Anti Emetic, 5-HT inhibitor)
• Octreotide Injection 50, 100, 500 mcg/ml single dose (1 ml in 2 ml vial) and 200, 1000 mcg/ml multidose vial (5 ml in 5 ml vial) (Somatostatin, Growth Hormone Inhibitor)
• Zoledronic Acid Injection 4mg/5 ml liquid concentrate (Bisphosphonate, for the prevention of fractures in Cancer patients
• Somatropin For Injection 5mg Lyophilised powder (Human Growth Hormone)
• Teriparatide Injection 750 mcg in 3 ml (Parathyroid Hormone)
• Granulocyte – Colony Stimulating Factor (Filgrastim) Injection 300mcg/ml & 480mcg/1.6 ml (Treatment of Chemoptherapy induced Neutropenia)

We would be offering 7 products in this category. The following products are at advanced stages of development:

• Latanoprost 50 mcg/ml Ophthalmic Solution (Prostaglandin)
• Olopatadine HCl 0.1 %Ophthalmic Solution (Anti Histaminic, Allergic Conjunctivitis)

• 21 APIs with DMFs
• 19 APIs with Technical Packages and
• 14 APIs under development

USV’s API’s are marketed to Customers in International Markets around the globe.

Commercially available:

• Octreotide (Somatostatin, Growth hormone inibitor)
• Bivalirudin (Anti-thrombotic agent)
• Eptifibatide (Anti-thrombotic agent)

Under development:

• Pramlintide (Amylin analog, Type II diabetes)
• Exenatide (GLP-1 analog, Type II diabetes)
• Desmopressin (Diabetes incipidus)

Finished Products dossiers of these peptides are also under development.

Our solid orals portfolio comprises of immediate release & complex modified release formulations.

• 5 Solid Orals launched in US & 25 Solid Orals under development or ongoing Pilot/Pivotal bioequivalence studies. These are marketed through our US affiliate Indicus Pharma.
• 4 Solid Orals launched in Europe and 10 solid oral dossiers are on offer for EU market. 15 solid orals under development or ongoing Pilot/Pivotal bioeqivalence studies.

These are manufactured at our cGMP compliant plants in India which are ISO 14001 and OHSAS 18001 certified.