ISSAR offers standardized and uncompromised quality of Peptide Drugs based on the project needs. Our company’s research and development is in accordance with the ICH and USP guidelines. We are cGMP approved and equipped with a US-FDA-compliant manufacturing facility.
The Quality support is initiated and adhered to at every stage of drug development process and continued even after the product is delivered.
• Recognition of quality needs when generating a quote.
• Confirming an order.
• Designing the most suitable manufacturing process.
• Controlling product quality at each production step.
• Informing clients in a timely fashion.
• Conducting finished product testing.
• Generating the Certificate of Analysis (CoA).
• Releasing the final product.
Quality support further continues after product release in the form of Stability studies and Regulatory filing assistance.
• Peptides are naturally occurring, small biological molecules made of short chains of amino acids linked by a peptide bond.
• Peptides typically contain 2-50 amino acids, therefore easily absorbed by the body when compared to proteins which are larger in size.
• Peptides contain amino acid sequences which control and coordinate all cellular functions and intracellular communication.
• Peptides are highly target specific, safe and non-toxic as their degradation products only involve simple amino acids.
Xylentra® contains an active drug substance called Genopep®. Genopep® is a 23 amino acid peptide composed of three specific amino acids known as Alanine (A), Phenylalanine (F) and Lysine (K) comprising the peptide sequence. The counter ion associated with cationic side chains in the peptide is the acetate ion.
It is available in the form of Xylentra® cream (Genopep 0.05%). Regular use of the cream results in:
• Stimulation of fibroblast and keratinocyte growth factors
• Potent wound healing
• Broad spectrum anti-microbial activity
• Prevention of scar
Designed as a broad spectrum anti-bacterial for the treatment of burn wounds.
• Use this medicine according to the dosage prescribed by your doctor.
• Use for 4 weeks or till the day of complete wound healing or infection
• The measured quantity of cream should be applied to the affected area.
• If dressing is required, the cream should be covered with Plain / Vaseline gauze.
• The cream should be applied to the affected area once in a day, generally for a period of 28 days.
• After the dosing period, the cream can be gently rinsed off using saline/water.
When Xylentra® is applied on the burn wound area, it stimulates fibroblast and keratinocyte growth factors and inhibits the growth of the commonly occurring bacteria including the most resistant forms. Thus, it controls infection without producing side effects.
Xylentra® cream provides an optimum physiological environment for regeneration, repair, and spontaneous healing without further damage to the viable tissues.
The Xylentra® cream is formulated to spread easily without adhering to the skin. Xylentra® effectively controls the infection(s) while treating burn wounds without producing any adverse effects.
• This medicine is only for external use and topical application.
• It should be sold by retail on the prescription of registered medical practitioner only.
• Xylentra® cream should not be prescribed to patients with a history of hypersensitivity to it.
• Adequate human data on use during pregnancy is not available.
• Keep out of reach of children.