Wednesday 28 September 2022

Medical uses of Melphalan Injection

Melphalan belongs to a group of drugs called cytotoxics (also called chemotherapy). It is approved in order to be used for the treatment of cancer. It works in order to reduce the number of abnormal cells formed in the body. 

The melphalan 50 mg injection is specifically used for:

  • Multiple myeloma: a type of cancer that forms from cells in the bone marrow called plasma cells. Plasma cells help in order to fight infection and disease by producing antibodies. 
  • Advanced cancer of the ovaries
  • Childhood neuroblastoma: cancer of the nervous system. 
  • Malignant melanoma: skin cancer. 
  • Soft tissue sarcoma: cancer of the muscle, fat, blood vessels, fibrous tissue, or other supporting tissue of the body.

Approval: In the year of 1964, Melphalan was approved for medical use in the United States.

Melphalan specifically belongs to the class of nitrogen mustard alkylating agents. It acts in order to interfere with the formation of DNA and RNA. 

Dosage Form: Melphalan comes in the form of injection generically and under the brand name Alkeran. Melphalan should only be prescribed for you by a specialist healthcare professional, experienced in order to treat blood problems or cancer. 

The recommended dose of melphalan injection can be administered as an infusion into your vein or as a perfusion to a particular part of the body through an artery.

Your healthcare provider will determine how much melphalan you will have. The amount of this medication depends on:

  • your body weight or body surface area (a specific measurement taking into account your weight and your size). 
  • other medicines you are having
  • your disease
  • your age
  • whether or not you have kidney problems.

When you're administered melphalan, your healthcare team will take regular blood tests. This is in order to check the number of cells in the blood. Your healthcare professional may sometimes change your melphalan dose as a result of these tests.

Side Effects: Side effects of melphalan are usually mild and not life threatening. The commonly reported side effects may include fatigue, decreased WBC count, decreased lymphocyte count, decreased platelet count, diarrhea, nausea, hypokalemia, anemia, and vomiting.

Cost: The melphalan price in India may vary depending on the wholesaler/pharmacy and of course the brand you choose. The cost of melphalan ranges from around 2,199 INR to 2,500 INR for a supply of vial of 1 injection. 


Polykris (Polymyxin-B): All you need to know about

Introduction: Polymyxin-B is an antibiotic drug, comes under the branded generic name Polykris. Polykris is marketed by Ikris Pharma (Pharmaceutical Wholesaler). Polykris is introduced for the treatment of meningitis, pneumonia, urinary tract infections and sepsis. It is effective for several Gram-negative infections. Although, it is ineffective for Gram-positive infections. Polykris contains a Lyophilized form of polymyxin b sulphate as an active ingredient. 

Indications for Use: Polymyxin-B sulfate is a drug of choice to treat infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. aeruginosa.

This medication may also be used topically and subconjunctivally to treat infections of the eye caused by susceptible strains of Ps. aeruginosa.

The polymyxin b sulphate may be used in serious infections caused by susceptible strains of H. influenzae, specifically in meningeal infections, Escherichia coli, specifically in urinary tract infections, Aerobacter aerogenes, specifically in bacteremia and Klebsiella pneumoniae, specifically in bacteremia, when less potentially toxic medicines are not useful or contraindicated.

Dosage and Administration: Dosage and administration information for polymyxin B USP 500000 IU (Polykris) varies widely depending on the reference used. It should be used as directed by a healthcare professional. 

Intravenous (children, adults):

  • 15,000 to 25,000 units/kg/day (normal renal function)
  • 15,000 units/kg/day (renal impairment)
  • Total daily polymyxin-b dose not to exceed 25,000 units/kg/day

Intravenous (adults):

  • 12,500 to 15,000 units per kg (TBW) administered over one hour every 12 hours. 
  • No dose adjustments are required in patients with renal impairment. 
  • Total daily polymyxin-b dose: 30,000 units/kg/day.

Side Effects: The commonly noted side effects of polymyxin b when used by injection include kidney problems, neurological problems, fever, itchiness, and rash. Injections into muscles may result in significant pain. Other serious side effects of polymyxin may include anaphylaxis, fungal infections, and muscle weakness. It is not clear if the use of this drug during pregnancy is safe for the fetus.

Warnings and Precautions:
  • Polymyxin-B injection need to be used where sensitivity suggests more commonly used systemic antibacterial agents may be contraindicated or ineffective due to bacterial resistance.
  • Polymyxin Injection, if prescribed for intravenous, intramuscular or intrathecal administration, needs to used only in hospitalized patients under precise monitoring for kidney function as well as neurological signs/symptoms.
  • In order to reduce the development of drug-resistant bacteria and maintain the impact of polymyxin-B sulfate and other antibacterial drugs, polymyxin-B should be considered only to treat/prevent infections that are proven or strongly suspected to be caused by the susceptible bacteria.
  • Patients who are known to hypersensitive to polymyxins, including polymyxin B sulfate, or to any component of the container should not use this medicine. This injection is contraindicated in patients with myasthenia gravis.
  • The concurrent/sequential administration of anaesthetic and other neurotoxic medicines needs to be avoided with Polykris treatment. The neurotoxicity of this drug can result in respiratory paralysis from neuromuscular blockade, mainly when the medicine is given soon after muscle relaxants and/or anaesthesia. In case signs of respiratory paralysis occurs, assist respiration and withdraw the medicine.
  • Injection Polymyxin B sulphate is not active and therefore do not use to treat bacterial infections caused by gram-negative bacteria (Proteus spp., Morganella spp., Providencia spp., Serratia marcescens, Neisseria spp., Burkholderia spp.), all gram-positive bacteria and anaerobes.
  • The intramuscular, intravenous, or intrathecal administration of Polymyxin injection should be restricted to hospitalized patients so as to provide constant clinical supervision. Do not exceed the maximum dosage 2.5 mg/kg/day or a total of 200 mg/day in patients with normal renal function.

Contraindications: The polymyxin b injection USP is contraindicated in recipients with a prior history of hypersensitivity reactions to it.

Drug Interactions:

Use of neuromuscular blockers (curariform muscle relaxants) and neurotoxic medications (e.g., ether, tubocurarine, succinylcholine, gallamine, decamethonium, sodium citrate) is not recommended. 

Do not use concomitant nephrotoxic drugs when feasible (calcineurin inhibitors, IV contrast, vasopressors, loop diuretics, aminoglycosides, ACEI, NSAID, vancomycin, rifampin). 

How Supplied: Polykris (polymyxin antibiotic) is generally supplied as 500,000 units, powder for injection. 

Storage: Before the reconstitution, store it at controlled room temperature 15° to 30°C (59° to 86°F). Protect from light. Retain in carton until time of use.

Following the reconstitution, polymyxin b sulfate must be stored under refrigeration, between 2° to 8°C (36° to 46°F). And any unused portion is discarded after 72 hours.

Cost: A patient weighing between 70 kg to 100 kg and receiving a dose of 30,000 units/kg/day would use 5-6 vials of polymyxin B sulfate, which would cost reasonably not expensive. To know the polymyxin b injection price (Polykris) for a 500MU vial, please get in touch with Ikris Pharma immediately. Furthermore, One can reach out to us by either calling our Toll-Free Number: 18008891064 or sending a WhatsApp message to +91 8130290915.

Note: The piece of information provided about "Polykris (Polymyxin-B): All you need to know about" in this article is just for informational purposes and is not served as a substitute for the medical treatment, consultation, diagnosis, of a qualified doctor.

Wednesday 7 September 2022

Contract Manufacturing In India: Third-Party Manufacture




 According to a late 2016 report by Technavio, the global pharmaceutical contract manufacturing market was valued at 65.10 Billion USD in the year of 2016, and by the year of 2022, the same is estimated to touch 94.38 Billion USD. 


In terms of volume and value, India is the 3'rd and 13'th largest Pharma manufacturer respectively. The country is contributing approximately 10% to global production.


The industry of India Pharma as a whole grew by 18% for the last decade. Clearly, the facts and figures of the industry for the past few years are evidence that India has not only entered the global Pharma map, but is here to stay.


India has a vital role in the production and supply of medicines at international level, as, currently more than 80 percent of the FDA-approved antiretroviral medicines used globally in order to combat AIDS are significantly supplied by the Indian pharmaceutical companies/firms.


What is Contract Manufacturing: Contract manufacturing typically refers to the outsourcing of certain production activities of a pharmaceutical company/firm to 3'rd-party vendors. This could include the outsourcing of the production of parts, components, or the finished product itself. For instance, the pharmaceutical companies/firms share the chemical composition or formula of a medicinal product with pharmaceutical CMO (Contract Manufacturing Organizations) which in turn mass manufacture them at their facilities.


The high degree talent pool and best affordable labour in terms of comparative costs have established India one of the most preferred places for contract manufacturing and firms from Europe and USA and of late from Japan have already started shifting towards India in a significant way mostly through collaborative settings and facility sharing.


Contract manufacturing is progressively recognized as a strategic choice by Pharma players to enlarge their global market footprint for zillions of reasons. The major drivers among others for the growth in Pharma contract manufacturing are:


  • Dwindling profit margins in highly competitive global Pharma marketplace;

  • Growing demand for generic medicines; patent expiration of significant therapeutic brands;

  • Demand for up-to-date processes;

  • Requirement for high-quality & D facilities and cost-effective production technologies that meet the global regulatory requirements;

  • Initiatives by government in healthcare sector;

  • Innovation/advancement in biologics and great potency API; and

  • Escalation in the incidence and growth rate of cancer, cardiovascular diseases, diabetes and psychological illnesses.


Role of Ikris Pharma Network (IPN) in Contract Manufacturing: Ikris Pharma Network provides Contract manufacturing services to the pharmaceutical companies / Hospital for manufacturing products under their brand / private label manufacturing. This is as per the regulatory requirements of the specific country. India is a well-known hub of World Pharmaceutical Manufacturing.


There are so many advantages for getting pharmaceutical medicinal products manufactured from India. India is engaged/involved in providing or supplying best quality Generic medicines to the world. There are over 10,500 manufacturing companies, based in India. There are over 600 manufacturing plants in India, approved by USFDA.


If you're looking for Contract Manufacturing/Private Label Manufacturing, then Ikris Pharma Network (IPN) can be your one stop solution. Please get in touch with us either via our TOLL-FREE: 1800-889-1064, Or Call/WhatsApp: +91 8130290915, Or Email: info@ikrispharmanetwork.com. IKRIS'ians are here for you whenever you need us.