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Amphotericin B
Karnataka

10 vials of Amphotericin B missing from locker at Victoria Hospital

by Vaishali Sharma
written by Vaishali Sharma

Ten vials of Amphotericin B, used to treat the deadly fungal infection Mucormycosis, were reportedly stolen from the locker of Victoria Hospital in Bengaluru on May 30.

In the police complaint filed on May 31, Dr. Srinivas Ramakrishna V, Resident Medical Officer of Victoria Hospital, said the vials were stored in a locker on the seventh floor of the Master Plan Building. The stock had been verified by two doctors and the staff.

The keys were then kept at the table of the nursing station. The theft came to light when the next shift doctor checked the stock.

The police have issued a notice to all the doctors and staff on duty to appear for questioning.

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Pharma News

Celon launches an emulsion-based drug to treat the deadly Black Fungus in COVID–19 patients

by Vaishali Sharma
written by Vaishali Sharma

Hyderabad, May 31st , 2021: Hyderabad based specialty biopharmaceutical manufacturer, Celon Laboratories, announced the launch of an alternative drug – Amphotericin B Emulsion, for the treatment of Mucormycosis, commonly known as Black Fungus. The drug is set to provide much needed respite to patients reeling under the severe impact of the second wave of
COVID-19 and the resultant Black Fungus.

Amphotericin B, is crucial to the treatment of Mucormycosis, of which a sudden resurgence is being witnessed off late among COVID-19 patients, across India. Though Celon has been manufacturing Liposomal Amphotericin B since 2013, market demands were not met due to the
unavailability of a critical ingredient sourced from Germany — lipoids. To bypass the bottleneck caused by this sourcing obstacle and increase production of this medication, Celon developed an alternative, an emulsion-based formulation.

Exhaustively developed by Celon’s in-house R&D team in a record three weeks, the emulsion- based formulation will provide leading hospitals and COVID-19 treatment centers with increased resources to treat the Black Fungus. Celon will manufacture 10,000 vials per day, which will ensure relief for approximately 6,000 patients monthly.

Celon Labs’ Managing Director, Mr. M. Nagesh Kumar, spoke of Celon’s role during India’s second wave of COVID-19: “Celon Labs is deeply committed to supporting the ongoing efforts to combat the Covid-19 pandemic during this deadly second wave and to save as many lives as possible. The emulsion-based formulation is an ideal alternative to Liposomal Amphotericin B to
combat the Black Fungus. The company will start supplying the domestic market soon.”

Additionally, the Chairman of Celon, Mr. Hocine Sidi-Said, expressed his gratitude to employees for achieving this important milestone: “I am delighted to see that Celon Labs has mobilized its talents and expertise to swiftly respond to this pressing medical need. I am grateful to the team at Celon Labs who have made the launch of Amphotericin B Emulsion
possible.”

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Amphotericin B
Madhya PradeshPharma News

Indore-based Modern Laboratories to manufacture Amphotericin B

by Vaishali Sharma
written by Vaishali Sharma

The Madhya Pradesh government has given permission to the Indore-based Modern Laboratories to manufacture Amphotericin B drug used in the treatment of Black Fungus, White Fungus, and Yellow Fungus.

“The government gave the permission within 72 hours. Now, we will start production and start supplying injections in the market in 15 days,” said Anil Kharia, Chairman, Modern Laboratories on Sunday.

“We will work with a capacity of manufacturing 10,000 injections daily and our priority will be to give them first to Madhya Pradesh and then to other states. This injection will be in the emulsion form. The price in the market will be around Rs 3,000, while we will give the government around Rs 1,500,” he said.

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drug
Pharma News

Zydus Cadila and Taiwan’s TLC to collaborate to market Black fungus drug AmphoTLC

by Vaishali Sharma
written by Vaishali Sharma

Zydus Cadila and Taiwan-based specialty pharmaceutical firm TLC on Wednesday said they have signed a pact to market Liposomal Amphotericin B, a critical drug to treat mucormycosis (black fungus), in India.

The companies have announced signing of an agrement to commercialise AmphoTLC (Amphotericin B Liposome for Injection 50mg) in India, Zydus Cadila said in a statement.

Under the terms of the agreement, TLC will manufacture and supply AmphoTLC on a non-exclusive basis to Zydus, and Zydus will commercialise the drug in India, it added.

‘With India facing an acute shortage of the drug to treat mucormycosis, we are making this critical drug available in India on an immediate basis,’ Cadila Healthcare MD Sharvil Patel said.

The need of the hour is to tackle this life-threatening infection with a safe and effective therapy, he added.

TLC President George Yeh said, ‘…we will be delivering the first batch of AmphoTLC to India to help assuage the urgent need for one of the safest and most effective antifungal drugs very soon.’ The Central Drugs Standard Control Organization has approved the new drug application (NDA) of TLC for Amphotericin B Liposome for Injection 50mg for immediate importation as per approved usage and indication, Zydus Cadila said.

With black fungus cases rising in India in recent days, AmphoTLC will address the country’s acute Liposomal Amphotericin B shortage, it added. Mucormycosis is a serious fungal infection, also known as black fungus, and COVID-19 associated mucormycosis is life-threatening, the statement said. AmphoTLC is a Liposomal Amphotericin B injection indicated for severe systemic fungal infections such as mucormycosis, it added.

Shares of Cadila Healthcare, the listed entity of Zydus Group, were trading at Rs 626.45 per scrip on BSE, up 0.64 per cent from the previous close. 

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Amphotericin B
Pharma News

VAV Life Sciences ramps up production of crucial lipid ingredients needed for Amphotericin-B

by Vaishali Sharma
written by Vaishali Sharma

Mumbai-based VAV Life Sciences is ramping up the production of crucial lipid ingredients needed for manufacturing liposomal amphotericin-B, the drug used for treating mucormycosis. Due to the surge in cases of mucormycosis, India is currently facing an acute shortage of these raw materials, leading to hindrances in the production of amphotericin-B class of drugs, the company said in a statement.

To keep up with the rising demand from the pharmaceutical industry for these lipid ingredients to manufacture the medication, VAV Life Sciences has taken immediate steps to increase the production of the crucial lipids threefold within the next three months, according to the statement.

The statement alos said, “The company plans to expand its present capacity of 21 kg per month to 65 kg per month, by August 2021. This would help pharmaceutical companies produce about three lakh vials of liposomal amphotericin-B. VAV will also further increase its capacity to 130 kg per month by December, which would add approximately six lakh vials of the medication to the pharmaceutical supply chain, by the end of 2021. VAV will manufacture the lipid ingredients at its EU cGMP-certified facility under its subsidiary company, VAV Lipids, based at Ratnagiri in Maharashtra.”

Speaking of the company’s plans to expand production, Arun Kedia, Managing Director, VAV Life Sciences, said, “The unprecedented demand of liposomal amphotericin-B has put tremendous pressure on the supply chain for raw materials. Since our company plays such a crucial role in the supply chain, we are working round-the-clock to keep up with the demand from pharmaceutical companies for these crucial ingredients that will help them manufacture this medication in sufficient quantities.”

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arrested
States Medical News

Two booked for black marketing of Amphotericin B

by Vaishali Sharma
written by Vaishali Sharma

Haryana Police, along with Drug Control authorities has arrested two persons from Rohtak on Monday on the charges of selling anti-fungal drug Amphotericin B, used for the treatment of mucormycosis.

The accused have been identified as Rahul Chauhan and Bhiwani, both trying to sell one vial of Amphotericin B for Rs 12000.

Police received information that two employees of a Pharma Company had been selling anti-fungal drug at many timed the original price. Based on the input, a joint team of Special Task Force (STF) and Drug Control Officer was constituted and a decoy customer was sent, who demanded 12 injections from accused. The deal was finalized at Rs. 12000 per vial. The conversation continued for upto four days and finally an advance of Rs 72000 was credited into the account through Google Pay.

A case has been registered against them in Rohtak and further probe is underway.

The spokesperson said that police would continue to be vigilant about the black-marketing of anti-fungal and other drugs. He also urged people to report to police if they come to know of such cases of black-marketing.

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Amphotericin B
MOHFW newsNational & International News

MoHFW and MEA to boost production of Amphotericin-B domestically

by Vaishali Sharma
written by Vaishali Sharma

The Health Ministry on Friday along with Department of Pharmaceuticals and the Ministry of External Affairs are making proactive efforts for significantly ramping up domestic production of Amphotericin-B drug, the Centre said on Friday.

Currently, there are five existing manufacturers of Amphotericin-B in the country and one importer. These are: Bharat Serums & vaccines Ltd, BDR Pharmaceuticals Ltd, Sun Pharma Ltd, Cipla Ltd, Life Care Innovations, Mylan Labs (importer).

The production capacity of these companies was extremely limited in the month of April 2021. As a result of the handholding by Government of India, these domestic manufactures will cumulatively produce 1,63,752 vials of Amphotericin-B in May 2021. This will be further ramped up to 2,55,114 vials in the month of June 2021.

Apart from this, efforts are being made for supplementing the domestic availability of this anti-fungal drug through import. In May 2021, 3,63,000 vials of Amphotericin-B will be imported, thereby resulting in total availability in the country (inclusive of the domestic production) of 5,26752 vials.

3,15,000 vials will be imported in June 2021. Hence, along with the domestic supply, the countrywide availability of Amphotericin-B will be enhanced to  5,70,114 vials in June 2021.

As a result of the proactive efforts by Union Ministry of Health, five more manufacturers have been given the license to produce the anti-fungal drug within the country. These are:

  1.  NATCO Pharmaceuticals, Hyderabad
  2. Alembic Pharmaceuticals, Vadodara
  3. Gufic Biosciences Ltd, Gujarat
  4. Emcure Pharmaceuticals, Pune
  5. Lyka, Gujarat

Cumulatively, these companies will start producing 1,11,000 vials of Amphotericin-B per month from July 2021. The Union Health Ministry and Deptt. of Pharmaceuticals are together trying to proactively facilitate these five manufacturers to prepone some of this production so that these additional supplies begin in June 2021.

Over and above this, Union Ministry of Health in collaboration with MEA is also actively exploring other global sources from where the Amphotericin-B drug can be imported. Union Health Ministry is also trying to procure other antifungal drugs which can be used in treatment of Black Fungus.

In the recent days, several States and UTs have reported an increasing number of patients suffering from COVID complications in the form of Mucormycosis, popularly known as Black Fungus. There is also a reported shortage of Amphotericin-B, an anti-fungal drug used for treatment of the Black Fungus disease.

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Amphotericin B
Pharma News

Genetek Lifesciences to manufacture Amphotericin B injection for black fungus treatment

by Vaishali Sharma
written by Vaishali Sharma

Genetek Lifesciences of Wardha, on the initiative of Union Minister Nitin Gadkari, has received FDA approval to make Amphotericin B injection for black fungus injection during the Covid-19 period, a statement issued by the minister’s office said.

Its production will begin in the next 15 days at its Wardha plant.

Right now the cost of an injection is Rs 7,000 and people are not getting it easily.

The injection made in Wardha will available for just Rs 1,200, it added.

A total of 20,000 injections per day will be manufactured in the plant.

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Mucormycosis
Government Policies NewsPharma News

GoI to increase production of Amphotericin B amid rising cases of Mucormycosis

by Vaishali Sharma
written by Vaishali Sharma

Amid a sudden increase in demand observed in some states for Amphotericin B which is being prescribed by physicians to patients suffering from Mucormycosis, a post COVID complication, the Government of India is engaging with the manufacturers to ramp up production of the drug, said the Ministry of Chemicals and Fertilizers on Wednesday.

The ministry further stated that the supply position is expected to improve with extra imports of this drug and an increase in its production domestically.

After reviewing the stock position with the manufacturers/importers, and the demand pattern of Amphotericin B the Department of Pharma, had on May 11, 2021, allocated this drug amongst the States/UTs based on expected supply that will be available from May 10 to May 31, 2021, stated the ministry.

The arrangements for supply will be monitored by National Pharmaceuticals Pricing Authority (NPPA), said the ministry.

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