Indian Gov’t Bans Exports of Potential COVID Drug; Companies Update Mfg

By Miranda Greenberg -

March 26, 2020

India’s Directorate of Foreign Trade has issued a ban to prohibit the export of hydroxychloroquine and its formulations, which is being evaluated as a potential treatment against COVID-19. Meanwhile, Mylan, Novartis, Teva, Amneal Pharmaceuticals, and Ipca Laboratories have provided updates on their manufacturing and supply plans. These actions follow the US Food and Drug Administration announcing earlier this month (March 2020) that it was investigating hydroxylchloroquine ad

Indian Gov’t Imposes Export Ban on Hydroxychloroquine, a Potential COVID-19 Treatment
The Directorate of Foreign Trade in the Department of Commerce, Ministry of Commerce & Industry in India has issued a ban to prohibit the export of hydroxychloroquine and its formulations, which is being evaluated as a potential treatment against COVID-19, effective immediately on March 25, 2020. Hydroxychloroquine, a drug used to treat malaria, lupus, and rheumatoid arthritis, is in high demand as a potential treatment of severely ill COVID-19 patients. The export ban applies to all shipments of hydroxychloroquine except under the following conditions: (1)  export is made to fulfill export obligations under any advanced licensure made prior to the March 25, 2020 notification of this export ban; (2) exports will be allowed to fulfill irrevocable  letters of credit that were issued prior to the export ban or where full advanced payment has been received by the exporter in India, subject to showing documentary evidence; and (3) export of product is made on humanitarian basis, subject to the approval of the Ministry of Trade on a case-by-case basis. 

Source: India’s Directorate of Foreign Trade


 

Mylan Ramps Up US Mfg of Hydroxychloroquine for COVID-19 Treatment
Mylan reports that it has restarted production of hydroxychloroquine sulfate tablets at its West Virginia manufacturing facility to meet the potential for increased demand resulting from potential effectiveness of the product in treating COVID-19.

Mylan's hydroxychloroquine sulfate tablets are approved by the US Food and Drug Administration (FDA) for the treatment of malaria, lupus erythematosus, and rheumatoid arthritis. Although the product is not currently approved for use in the treatment of COVID-19, it is listed by the World Health Organization as a drug under investigation for efficacy against the novel coronavirus. 

Mylan expects to begin supplying product by mid-April (April 2020), and with the active pharmaceutical ingredient that they currently have available, will be able to ramp up manufacturing to provide 50 million tablets to potentially treat a total of more than 1.5 million patients. The potential use of this medicine for COVID-19 related treatment is pending additional FDA and other regulatory body guidance.

Source: Mylan


 

Novartis To Donate 130 million Doses of Hydroxychloroquine for COVID-19 Response
Novartis has announced its commitment to donate up to 130 million doses of generic hydroxychloroquine to support the global COVID-19 pandemic response. Hydroxychloroquine and a related drug, chloroquine, are currently under evaluation in clinical trials for the treatment of COVID-19. Novartis says it is supporting ongoing clinical trial efforts and will evaluate needs for additional clinical trials.

When supported for use in COVID-19-infected patients by regulatory authorities, Novartis intends to donate up to 130 million 200-mg doses by the end of May (May 2020), including its current stock of 50 million 200-mg doses. The company said it is also exploring further scaling of capacity to increase supply and is working with manufacturers to meet global demand.

Novartis’ Sandoz Division, the company’s generic-drug business, currently only holds a registration for hydroxychloroquine in the US and Novartis says it will pursue appropriate regulatory authorizations from the FDA and the European Medicines Agency. Novartis says it will work with stakeholders including the World Health Organization to determine the best distribution of the medicine to ensure broad access to patients most in need of this medicine globally. The company says it will ensure that patients currently depending on this medicine are not impacted by the donation.

Source: Novartis


 

Teva To Donate Potential COVID-19 Treatment, Hydroxychloroquine Sulfate
Teva Pharmaceutical Industries has announced the immediate (as announced on March 19, 2020) donation of more than 6 million doses of hydroxychloroquine sulfate tablets through wholesalers to hospitals across the US to meet t demand for the medicine as an investigational target to treat the novel coronavirus (COVID-19). The company is also looking at additional ways to address global need.

The company is also assessing additional production of hydroxychloroquine sulfate tablets is also being assessed and subsequently ramped-up materials are being sent to Teva from its ingredient supplier. Teva says it will ship 6 million tablets through wholesalers to hospitals by March 31, 2020 and more than 10 million tablets within a month.

Hydroxychloroquine sulfate tablets manufactured by Teva are approved by the US. Food and Drug Administration (FDA) for the treatment of malaria, lupus erythematosus, and rheumatoid arthritis. Although the product is not currently approved for use in the treatment of COVID-19, it is currently under investigation for efficacy against the coronavirus and has been requested by US government officials to be made available for use immediately. The company says it is also reviewing supply of both hydroxychloroquine and chloroquine globally to determine whether there are additional supply and access opportunities for patients.

Source: Teva Pharmaceutical


 

Amneal Pharmaceuticals Ramps Up Production of Hydroxychloroquine
Amneal Pharmaceuticals, a Bridgewater, New Jersey-based generics manufacturers, reports that it is ramping up production of hydroxychloroquine sulfate at several of its manufacturing sites and expects to produce approximately 20 million tablets between now (as of March 20, 2020) and mid-April (April 2020). The company says that those tablets will be made available nationwide through Amneal’s existing retail and wholesale customers as well as through direct sales to larger institutions in need. The company says it has already begun shipping product (as of March 20, 2020).

Hydroxychloroquine sulfate was first synthesized in 1946 and is in a class of medications historically used to treat and prevent malaria. Amneal’s hydroxychloroquine sulfate tablets are approved by the US Food and Drug Administration (FDA) to treat malaria, rheumatoid arthritis, lupus, childhood arthritis and other autoimmune diseases. Hydroxychloroquine is not approved for the treatment of COVID-19; however, it has been identified as a possible treatment for COVID-19,1 and the US government has requested its immediate availability.

Source: Amneal Pharmaceuticals


 

FDA Lifts Import Alert on Ipca Labs for Hydroxychloroquine and Chloroquine
Ipca Laboratories, a Mumbai, India-based pharmaceutical company, reports that the US Food and Drug Administration has granted the company two exceptions to the FDA’s import alert to the US imposed on the company to enable the company to export active pharmaceutical ingredients (APIs) and finished formulations of hydroxychloroquine sulfate and chloroquine phosphate, two products being investigated as potential treatments for the novel coronavirus (COVID-19).

The lifting of the import alert applies to hydroxychloroquine sulfate and chloroquine phosphate APls produced at the company's APls manufacturing unit situated at Ratlam, Madhya Pradesh, India, and hydroxychloroquine sulfate tablets produced at the company's formulations

manufacturing units situated in Pithampur, Madhya Pradesh and Piparia, Silvassa, India

Source: Ipca Laboratories