Bajaj healthcare gets FDA approval for manufacture of posaconazole API

With the rise of the second wave of covid-19 disease, India has seen mucormycosis, a black fungus, in epidemic proportions. Bajaj healthcare in its regulatory feeling said it’s going to launch posaconazole API.

Currently with mucormycosis being declared as epidemic in India there is severe shortage of treatment drug Amphotericin B. There is huge demand for the effective drug Amphotericin B in the market because of the large number of mucormycosis cases.

In this news of serial shortages about medicines there is a ray of good news. Bajaj healthcare has got approval to produce posaconazole API from the FDA India. In a few days it will start the manufacturing of the posaconazole API in India. The medicine is likely to be available in coming months as declared by Mr Anil Jain managing director Bajaj Healthcare.

About posaconazole

Currently posaconazole is available as oral suspension, sustained release tablet or injection form. For the serious infections injection form is preferable. It is a triazole antifungal drug.

How does posaconazole work?

It is the class of antifungal drugs that inhibit steroid synthesis in the fungal cell membrane. The fungal cell membrane is lysed and the fungus cannot grow in presence of posaconazole.

Thus in fungal infection posaconazole acts against the fungus and destroys the cell membrane of the formula and cures the fungal infection.

What are side effects of the Posaconazole?

Like all the other medicines, posaconazole has side effects. Those Side Effects are as listed below:

  • Diarrhea 
  • Pyrexia 
  • Nausea 
  • Hypokalemia 
  • Rash 
  • Headache 
  • Vomiting 
  • Epistaxis 
  • Abdominal pain
  • Peripheral edema 
  • Cough 
  • Constipation 
  • Hypomagnesemia 
  • Decreased appetite 
  • Hypertension
  • Thrombocytopeni
  • Upper abdominal pain

Is it safe for pregnant ladies?

Yet the safety data about posaconazole in pregnant ladies is lacking. Studies on animasl indicate the possibility of fetal harm inform of miscarriage and fetal defects.

Is it safe in lactating mothers?

Still the safety data about the posaconazole in lactating mothers is not available.

How is it administered?

In injectable form this medicine is administered mixed with D5 or dextrose 5% or 0.9% NS. It is administered as a slow IV infusion and never given as bolus. 

Is it already available in Indian market?

Yes it is already available in the Indian market with following brand names:

Brand nameCompany
Noxafil oral suspension 105 mlMsd pharmaceutical pvt lmt
Picasa 40 mg suspension oral 105 mlPicasa 300 mg injectionIntas pharmaceuticals
Posaone tabletsMsn Laboratories Pvt Ltd
Pocaaz O oral suspensionCadilla healthcare Ltd
Posanat tabletsNatco pharma
Poshope 300 mg inj 16.7 mlAbott healthcare
Posaconazole brand names

Against which fungus it is active?

Posaconazole being triazole antifungal drug it is active against following fungal infections:

  • Invasive Aspergillus & Candida Infections
  • Oropharyngeal Candidiasis
  • Against mucormycosis it is used as off label medicine in some cases.

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