Cipla partners with MSN Laboratories for marketing and distribution of generic Xeloda® (Capecitabine Tabs 150mg and 500mg)

Press Release

Cipla USA, Inc., (“Cipla”) a subsidiary of Cipla Limited, today announced that it has secured rights from MSN Laboratories Private Limited to market & distribute Capecitabine 150mg and 500mg tablets in the United States of America. The product is available immediately.

The Capecitabine 150mg and 500mg tablet is an AB-rated generic therapeutic equivalent version of Genentech’s Xeloda®. Capecitabine tablets are indicated as a single agent for adjuvant treatment in patients with Dukes C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred, and also indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.

As per IQVIA (IMS Health), Xeloda® and its generic equivalents had sales of approximately $178M for the 12-month period ending June 2018 in the United States.

About MSN Group
Founded in 2003 with a mission to make health care affordable, the MSN Group based out of Hyderabad is one of the fastest growing research-based pharmaceutical company in India. MSN has 10 API (including Oncology) and
five finished dosage facilities out of which three in Hyderabad, one both in USA & Myanmar. MSN Labs has an integrated R&D Center for both API and product formulation under one roof. The company’s core strategy will be to focus on high barrier of entry & first to market paragraph 4 products. MSN customer base exceeds 250 customers with a global presence in 65 countries throughout US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. With more than 350 National & International patents filed, MSN’s product basket offers 300 APIs & 200 Formulations covering 35 major therapies.
http://www.msnlabs.com

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Patents and patients

Of patents and patients

Pharmaceutical giant Cipla’s archive is worth emulating for all legacy companies. This diarist toured it last week and was surprised to see the effort gone into chronicling the company’s eight-decade-long journey. A visitors’ book from 1939, signed by both Mahatma Gandhi and Sardar Vallabhbhai Patel; a 1939 photograph of a Cipla-monogrammed van, against the Great Pyramid of Giza; a photograph from August 15, 1947, with founder Khwaja Abdul Hamied and Dr Yusuf Khwaja Hamied, current non-executive chairman, as a child, celebrating with the staff.

Cipla founder Khwaja Abdul Hamied with son, Dr Yusuf Khwaja Hamied. Pics/Bipin Kokate

There are also letters, telegrams, brochures, photographs of the labs, catalogues, tins that contained Calcima ACD (calcium tablets), an inhaler from 1993, and paraphernalia from Dr Yusuf’s world-famous HIV/AIDS offer of providing medicines for less than a dollar a day in 2001: all of these have been pieced together from different sources. MK Hamied, non-executive vice-chairman and Dr Yusuf’s brother, tells us, “A few years ago, several factors such as the generational change in promoter leadership, new emerging business trends, the changing Indian and international pharmaceutical scenarios, etc, prompted introspection. The general desire in the promoter family was to ensure that Cipla’s rich legacy was not lost. Cipla’s story is in many ways the story of Indian pharma. Work on building the Cipla Archives repository and accumulating material, starting with oral histories, commenced in 2015.”

Mahatma Gandhi and Sardar Vallabhbhai Patel in 1939

Samina Vaziralli, executive vice-chairperson and MK’s daughter, says, “For me, as a third-generation Ciplaite, the Cipla Archives is the custodian and record-keeper of the rich past, present and future of Cipla. It serves as a daily reminder of the might of our legacy and the need to watch against resting on past laurels, and as motivation to keep moving onwards and upwards. In the current business atmosphere, I believe corporate archives provide that extra competitive edge. [They] demonstrate pride in the company’s legacy, but also prove that we treat our legacy with the seriousness and sense of responsibility it deserves.”


This article originally appeared in mid-day.com


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In Remote Villages, Surprising New Measures Save Children With Malaria

Malaria quickly kills toddlers. But rapid diagnostic tests, a new suppository drug and bicycle ambulances can buy enough time to get stricken children to hospitals.

During malaria season, children who live in remote villages are at tremendous risk. When parasites transmitted by mosquitoes swarm into the brain, the disease can kill within 24 hours.

Often parents do not realize quickly enough how close a toddler is to death. More than 90 percent of malaria deaths are in children under five years old.

Now, after 13 years of effort, a set of stopgap measures to keep youngsters alive long enough to get them to a clinic has been developed. Initial testing suggests the measures can dramatically cut death rates; in one pilot project in Zambia, they dropped by 96 percent.

The most important new element is artesunate delivered as a soft rectal suppository. Artesunate is the drug that hospitals inject into children in mortal danger from malaria infections of the brain. The new version comes in a form that can be given by a village health worker or even a parent.

Rectal administration gets the drug into the blood quickly and avoids the possibility that the child will vomit up the medication. Ideally, each two-dose box kills enough parasites to buy six to 12 more hours for a child to reach higher-level care.

The World Health Organization endorsed the idea of artesunate suppositories in 2005, but it was not until February that a version finally won full W.H.O. approval. It is made by Cipla, the Indian pharmaceutical company that in 2001 became the first to make inexpensive generic H.I.V. drugs for Africa.

A second artesunate suppository, by another Indian company, Strides, was approved in June.

Other advances that help save children with malaria include rapid diagnostic tests, training local health workers to recognize the disease and a fleet of bicycle ambulances.

The test gives a diagnosis in minutes with only a finger-prick drop of blood.

The ambulances are metal carts about six feet long and four feet wide that can be made in a local welding shop and attached to most bicycles. A mother and child can ride flat or sitting, and the cart can navigate dirt tracks too narrow for cars.

(Motorbike ambulances have been rolled out in India for use in roadless mountain areas and cities plagued by traffic jams, but they are wider and more expensive.)

The multipronged program was tested during the 2017-2018 malaria season in a Zambian district where villages could be up to 10 miles over dirt tracks from any formal medical care.

It dramatically cut child mortality rates, and in April the Bill and Melinda Gates Foundation released a video describing the program’s success.

An analysis released in August calculated that deaths were 96 percent lower than they would have been without the combination of suppositories, ambulances, test kits and extra training.

(The comparison was imperfect, because the 2017-2018 season in the analysis appears to have been more severe than the previous season, and local clinics were well prepared in advance. Still, only three children died, which was far fewer than local health officials had seen before.)

The pilot project was supported by the Medicines for Malaria Venture, a partnership founded in 1999 to pursue new malaria drugs, and Transaid, a British charity that works to improve transportation in poor countries.

Donald G. McNeil Jr. is a science reporter covering epidemics and diseases of the world’s poor. He joined The Times in 1976, and has reported from 60 countries. 


This article originally appeared in The New York Times

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A first in Morocco: CIPLA MAROC opens an inhaler manufacturing plant in the Rabat region for an investment of 60 MDH

Inaugurated by MM. Anas Doukali and MM. Moulay Hafid Elalamy, the plant will produce 1.5 million metered-dose inhalers annually

Rabat, Morocco, October 13, 2018: Cipla Maroc, subsidiary of the leading global pharmaceutical company Cipla Ltd, today announced the official opening of its manufacturing plant for metered-dose inhalers in Ain Aouda in the Rabat region.

A total of 60 million dirhams have been invested in this project. This is the first time that an industrial unit of this kind has opened in the Country.

The ceremony took place in the presence of Mr. Anas Doukkali, Minister of Health, Dr. Y.K. Hamied – Non Executive Chairman of Cipla, Mr Niravkumar B Sutariya, Second Secretary, Embassy of India in Morocco, Mr. Christos Kartalis – Executive Vice President- Emerging Markets and Europe of Cipla, Mr. Ali Sedrati – General Manager of Pharmaceutical Institute & Mr. Ayman Cheikh Lahlou – General Manager of Cooper Pharma, as well as representatives of local authorities and the national pharmaceutical industry.

Spread over a total area of 4,000 square meters, the Cipla Maroc plant offers an annual production capacity of 1.5 million HFA metered-dose inhalers. Around fifteen references will be manufactured on the site, and eleven will be distributed for the first time in Morocco.

The Cipla Maroc industrial unit is built as per the guidelines of the World Health Organization (WHO), as well as European and American regulatory authorities. The facility received regulatory approval from the General Secretary of Govt on 18th of June 2018.

“We are proud of this addition to our manufacturing footprint, a first for the region. With this, we not only strengthen our manufacturing, but also ties between Morocco and Cipla. This factory will leverage Cipla’s well known expertise and experience in the respiratory inhalation segment to help patients in Morocco and the neighbouring regions in keeping with our purpose of Caring for life.”

Christos Kartalis – Executive Vice President- Emerging Markets and Europe of Cipla Said

“Cipla, Phi and Cooper have made a smart distinctive investment in Morocco in the inhaler technology that is a first for the country and region. This would allow to reduce significantly our imports of this technology and it would improve our value added product’s offer for the exports markets”

Mr. Ali Sedrati – General Manager of Pharmaceutical Institute & Mr. Ayman Cheikh Lahlou – General Manager of Cooper Pharma added:

About Cipla Maroc:

Founded in 2015, Cipla Maroc is a joint-venture between the Cipla Ltd, headquartered in Mumbai (India), and its Moroccan partners Pharmaceutical Institute and Cooper Pharma It focuses on the production and marketing of pharmaceutical products of the highest quality.

About Pharmaceutical Institute

Establised in 1988, The Pharmaceutical Institute (PHI) is a national laboratory with Multinational standards. It manufactures its own range of generic medicines especially for chronic diseases and cancers in a concern for universal access with the best quality price/ratio.

About Cooper Pharma

Cooper Pharma has been established in Morocco sin 1933. Its products portfolio cover most of the key therapeutic classes through branded generics, in-licensed innovative products and OTC. The geographical reach covers Morocco, North Africa, West Africa, East Africa, GCC countries and Eastern Europe through a network of 8 manufacturing plants operated on its own or through JVs. Cooper Pharma has been approved in 2008 by the European authorities, in 2011 by the Saudi FDA and by several other health authorities”.

About Cipla Ltd:

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urology, cardiology and CNS segments are well-known. Our 44 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Mar’18), 4th largest in the pharma private market in South Africa (IQVIA MAT Jun’18), and is among the most dispensed generic players in the US. For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders.


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Child malaria deaths dramatically cut by suppository drug, shows Zambia study

Internally administered medicine allows crucial window of time for children in remote areas to reach healthcare facilities

A suppository form of a malaria-fighting drug could provide a lifeline to children in rural areas, drastically cutting the number of deaths caused by the disease.

A study in rural Zambia found that suppository drugs administered by community health workers provided a crucial window for children with severe malaria, allowing them to reach a health facility.

Each year, 445,000 people die from malaria, with more than 90% of deaths occurring in sub-Saharan Africa. Children under five are among those most vulnerable to the disease.

“If they don’t have immediate access to a facility, these are extremely vulnerable children,” said Pierre Hugo, director for Medicines for Malaria Venture (MMV), one of the research partners in the pilot project. “Their parasite count is through the roof, their red blood cells are almost totally destroyed. They’re literally on the brink of life or death.”

The research is published in advance of the World Health Organization’s annual malaria report, which is expected to call for greater investment in fighting the disease. Last year, the WHO warned that, for the first time in a decade, malaria cases were no longer falling.

The 12-month Zambia study was carried out in Serenje district, an area with high rates of malaria among young children. Communities in the district have limited access to medical care, and the nearest health facility can be 20km away.

During the pilot, child deaths related to severe malaria were cut dramatically, from 8% to 0.25%. There were three recorded deaths during the study period – 94 fewer than would previously have been expected in the timeframe, according to MMV.


All children suspected of having severe malaria were given rectal artesunate suppositories, a pre-referral antimalarial medicine. The suppository drug is effective because, unlike oral medication, it can be administered even if a child is unconscious or vomiting.

Children who received the suppository were then transferred to a health facility through the project’s emergency transport system, which was equipped with additional bicycle ambulances through the NGO Transaid. More than 1,000 cases of suspected severe malaria were referred by community health workers.

Once at the health facility, children were given injectable artesunate malaria medication, followed by a three-day oral antimalarial treatment course.

The WHO has recommended the use of artesunate suppositories in suspected cases of severe malaria for over 10 years, but until recently there was no quality-approved drug on the market.

“It’s not a product that’s widely used, its not a high commodity product, so for manufacturers it’s not an attractive treatment,” said Hugo.

MMV has worked with two pharmaceuticals, Strides Shasun and Cipla, to secure WHO pre-qualification for suppository malaria products.

It is hoped the same model could be adopted in other rural settings where there is a high prevalence of malaria and limited access to healthcare workers.


This article originally appeared in The Guardian


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