Products & Services

APIs & Lab Products

Active Pharmaceutical Ingredients (APIs)

USV has an aggressive API development program. We strive to be perceived as a reliable, responsive & competent API partner by our Customers. Our portfolio consists of a broad range of 54 small molecule APIs:

  • 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.

Peptides

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.

Solid Oral Portfolio

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.

Biosimilar Pipeline

Biosimilar%20Pipeline

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 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.

Opthalmic Product

Opthalmic%20Product

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)

Injectable

Injectable

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)

To,USV Limited

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