Pharma News – 13 August

Pharma News – 13 August 2020

Cipla’s Goa plant begins production of Remdesivir to meet the increased demand:

Pharma News – 13 August: The surge in the number of Covid-19 cases has increased the demand for Remdesivir. As current production capacity remains insufficient to meet this growing demand, pharmaceutical companies are ramping up their production.

In accordance with this scenario, pharma major Cipla Ltd. has also taken several measures to enhance its supply. The company has recently begun the production of Remdesivir in its plant in Goa. It expects this to supplement the existing production capacity and narrow the gap between demand and supply.

Pharma News – 13 August

The company had earlier made a contract with Daman-based Sovereign Pharma for the production of Remdesivir. It was revealed that Sovereign Pharma could supply around 50,000 to 95,000 vials of injectable per month. This decision was also taken to scale up the production but this again failed to fulfill the demand.

The total Remdesivir manufacturing capacity of Cipla lies around 8.6 million units of injections per annum.

Gilead Sciences Inc. is the developer of Remdesivir. This company had signed licensing agreements with seven companies in India for the production of Remdesivir. However, the drug regulator has approved only four of the drug firms. This includes Cipla, Mylan, Hetero Drugs and Jubilant Life Sciences Ltd. At present, Cipla is the company that has launched the cheapest version of Remdesivir. The generic version manufactured by Cipla is priced at Rs.4000 per vial.

Lupin pharma launches Zileuton extended-release tablets in the US :

On 11 August 2020, drug firm Lupin announced the launch of Zileuton extended-release tablets in the US[1] market. This drug is used in the treatment of asthma. It is being marketed in the strength of 600 mg and had received the USFDA’s[2] approval prior to marketing.

Zileuton extended-release tablet is a generic product of Lupin. It is the generic version of Zyflo CR extended-release tablets 600 mg that is produced by Chiesi USA Inc.

As per IQVIA[3] MAT[4] June 2020 data, the generic version had an annual sales of around USD[5] 40 million in the US.

Zileuton extended-release tablets are prescribed for the prophylaxis and chronic treatment of asthma. It can be taken by both adults and children of 12 years of age and above.

Abbreviation :

  • 1. United States
  • 2. United States Food and Drug Administration
  • 3. Formerly known as Quintiles and IMS Health, Inc
  • 4. Moving Annual Total
  • 5. United States dollar

Mankind Pharma and Daewoong Pharma collaborate for the clinical trial of Niclosamide for Covid-19 :

Pharma News – 13 August: Mankind pharma has been proactive in its search for the treatment of Covid-19. The drug firm is working on several Covid-19 programs and in accordance with this, it has made an announcement. The company recently announced its collaboration with the South Korea-based Daewoong Pharmaceuticals. This collaboration was done to investigate the effect of Niclosamide on Covid-19 treatment.

Pharma News – 13 August

The Indian subsidiary of Daewoong Pharma will initially work together with Mankind Pharma for conducting the Phase-I trials of Niclosamide. Daewoong Pharma has, however, emphasized that this would happen only if the results from the pre-clinical studies are positive.

Mankind Pharma has claimed that its formulation of Niclosamide is longer acting variant of the existing formulation. The drug firm claims that this alternative is free from the adverse effects that are commonly experienced after the administration of Niclosamide.

Pharma News – 13 August

In vitro tests of Niclosamide showed that it is 40, 26 and 15 times more potent than Remdesivir, Chloroquine and Ciclesonide respectively. This is in accordance with its antiviral action against SARS-CoV-2[1] virus.

Animal studies have also provided positive results. The intramuscular injection of Niclosamide was found to remove the virus from the lungs of the animals. This in turn counteracted the viral infection and also prevented the cytokine storm. 

Niclosamide is an anti-parasitic drug that helps to expel the parasitic worms and other internal parasites from the body. It does not cause any significant damage to the host.

Abbreviation : 1. Severe Acute Respiratory Syndrome- Coronavirus – 2

Digital Vision Pharma recalls cough syrups following report of life-threatening complications in a two-year-old:

Pharma News – 13 August: Digital Vision Pharma is a Kala Amb based Pharma company. This firm has recently been sailing through rough tides as its license was canceled in February 2020. This action was implemented owing to the deaths of 10 children in J&K[1] post consumption of the cough syrup manufactured by the company.  The cough syrup that led to this action is called Coldbest-PC syrup.

Another cough syrup produced by this company, Cofset syrup, has recently created yet another controversy for it. This syrup has induced life-threatening complications in a two-year-old girl after administration. This adverse effect is believed to be due to the presence of a toxic drug present in the syrup.

Pharma News – 13 August

Based on this, investigations were carried out to identify the toxic drug. It was revealed that both cough syrups were produced in September 2019 and that this batch was contaminated with diethylene glycol. This contaminant is a chemical compound that causes kidney failure and neurological toxicity.

The firm has already initiated the recall of around 100 unsold bottles of this cough syrup from Bengaluru and Kolkata. The company has also stopped the sale of this product.

Though the firm’s license remains canceled, the company had, however, sold approximately 2,800 bottles of this cough syrup. All these bottles were a part of the batch that was manufactured in September 2019. They were sold from September 2019 to December 2019. These bottles were sold to the markets of Punjab, Haryana, and Rajasthan.

Pharma News – 13 August

The identification of the toxic compound was done by the doctors of PGIMER[2], Chandigarh. They reported this incident to the DCGI[3]  following which the recall of this product was initiated. The authorities in Himachal Pradesh are currently trying to recall all the products to safeguard the lives of the patients. The pharma company has also agreed to cooperate with the investigation. It is currently awaiting the results of the samples taken from the firm.

Abbreviation :

  • 1. Jammu and Kashmir
  • 2. Postgraduate Institute of Medical, Education, and Research
  • 3. Drugs Controller General of India

Pharma News – 13 August: Zydus Cadila has launched Remdac at Rs.2800 per 100 mg vial in India :

On 13 August 2020, Zydus Cadila announced the launch of Remdac in the Indian market. Remdac is the drug firm’s generic version of Remdesivir. This generic version is priced at Rs.2800 per 100 mg lyophilized injection vial.

The company had signed a non-exclusive agreement with Gilead Sciences Inc in June 2020. This agreement allowed Zydus Cadila to sell and manufacture Remdesivir in India. Following this, the company began to develop the API[1] and also the production of Remdesivir in its manufacturing unit in Gujarat.

The company believes that the affordable price of Remdesivir will ensure its access to critical patients across the country.

Pharma News – 13 August

It has also ramped up the production of Hydroxychloroquine and Dexamethasone to meet the growing demands. The company is also engaged in the clinical trials of Pegylated Interferon Alpa 2b and Desidustat for the treatment of Covid-19. It has also supplied around 300,000  COVID Kavach Elisa diagnostic kits for surveillance purposes.

The plasmid DNA vaccine, ZyCov-D that is being developed by Zydus Cadila is currently in the phase-II stage. It is one of the forerunners of Covid-19 vaccines in India.

 Abbreviation : 1. Active Pharmaceutical Ingredient

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