PHARMA WISDOM: Pharma News

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Showing posts with label Pharma News. Show all posts
Showing posts with label Pharma News. Show all posts

Saturday 21 November 2020

Urgent Openings for Head - Quality Assurance - Pharmaceutical Sterile Formulations - Mumbai || Pulse HR Consultants

09:10:00 0

 

Dear Aspirant,

Greetings from PULSE HR CONSULTANTS!

We have urgent opening in one of our reputed pharma client based  at near Mumbai, and manufacturing of Injectables

Head - Quality Assurance - Pharmaceutical Sterile Formulations

Qualification: M.Sc/ M.Pharm/B.Pharm with 12 to 20 years exp in

- To handle team for Quality Assurance for Pharmaceutical Sterile formulations

- To guide team for various tasks

- To look after quality management system for pharmaceutical formulations company

- To face various regulatory audits like USFDA/ EU/ PICS and customer audits

- To investigate failures and work on CAPA

- To improve systems on continuous basis.

- To ensure quality of products

- To ensure that customer response is given on time.

- To do training and development of people in company

Please share the updated profile with CTC details to pavani@pulsehr.org

Regards,

Pavani.V

M/s. PULSE  HR CONSULTANTS

HYDERABAD


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Tuesday 4 August 2020

Sun Pharma launches FluGuard® (Favipiravir 200 mg) in India at Rs. 35 per tablet

19:25:00 1


Mumbai, August 04, 2020: Sun Pharmaceutical Industries Limited. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that it has launched FluGuard® (Favipiravir 200 mg) at an economical price of Rs. 35 per tablet, for the treatment of mild to moderate cases of Covid-19 in India. Favipiravir is the only oral anti-viral treatment approved in India for the potential treatment of patients with mild to moderate Covid-19 disease.

Commenting on the launch, Kirti Ganorkar, CEO of India Business, Sun Pharma said, “With over 50,000 Covid-19 cases being reported daily in India, there is an urgent need to provide more treatment options to healthcare professionals. We are launching FluGuard® at an economical price to make the drug accessible to more and more patients thereby reducing their financial burden. This is in line with our continuous efforts to support India’s pandemic response.”

The company will work closely with the government and medical community to ensure availability of FluGuard® to patients across the country. The stocks of FluGuard® will be available in the market from this week.

FluGuard® is the registered trade mark of Sun Pharma.


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Wednesday 29 July 2020

Hetero announces the launch of ‘Favivir’ (Favipiravir 200 mg) in India to treat mild to moderate Covid-19

23:42:00 0

Hyderabad, India; 29th July 2020: Hetero, one of India’s leading generic pharmaceutical companies and the world’s largest producer of antiretroviral drugs, today announces the launch of generic Favipiravir in India under the brand name ‘Favivir.’


Hetero has been granted the manufacturing and marketing approval for Favipiravir from the Drug Controller General of India (DCGI).

Favivir is the second drug developed by Hetero after Covifor (Remdesivir) used in the treatment of Covid-19. It is an oral antiviral medication that has demonstrated positive clinical outcomes.

Favivir improves treatment accessibility to a significant amount of Covid 19 patient population, which usually sustains mild to moderate symptoms. Hetero’s Favivir is priced at Rs. 59 per tablet and is marketed and distributed by Hetero Healthcare Limited. The product is available from today at all retail medical outlets and hospital pharmacies across the country and will be sold only on prescription. Backed by strong vertical integration capabilities, the drug is being manufactured at our world-class formulation facility in India, which has been approved by stringent global regulatory authorities such as USFDA and the EU, among others.
Source: Heteroworld.com
Click Here - for Official Announcement 


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Monday 6 July 2020

Mylan Secures Regulatory Approval for Remdesivir Lyophilized Powder for Injection 100 mg/vial in India for Restricted Emergency Use in COVID-19 Patients

16:30:00 0

HERTFORDSHIRE, England, PITTSBURGH, U.S. and BANGALORE, India, July 6, 2020 – Mylan N.V. (NASDAQ: MYL) today announced that the Drug Controller General of India (DCGI) has approved its remdesivir 100 mg/vial for restricted emergency use in India as part of the DCGI’s accelerated approval process to address urgent, unmet needs amid the evolving coronavirus 2019 (COVID-19) pandemic. The drug is approved for the treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children hospitalized with severe presentations of the disease. The drug will be launched under the brand name DESREM in India and will be available to patients in July at a price of INR 4,800, which is more than 80% less than the price at which the branded version of this product will be available to governments in the developed world.

Mylan will manufacture remdesivir in India at its world-class injectables facilities, which also make product for the U.S. and have been inspected by the U.S. Food and Drug Administration (FDA) for compliance with good manufacturing practices. The company continues to work extensively toward expanding emergency use access for patients in the 127 low- and middle-income countries where it is licensed by Gilead Sciences to do so, subject to reviews by national regulatory bodies and the Prequalification Program of the World Health Organization (WHO). The approval by DCGI in India represents the first for Mylan in these 127 markets.

Mylan President Rajiv Malik said: “Mylan and Gilead Sciences have partnered for many years to make high quality medicines available to people who need them and have made significant progress to reduce the incidence of infectious diseases, including HIV/AIDS, around the world. We commend Gilead for their continued leadership on this front, and also applaud and are proud to continue partnering with the DCGI for its ongoing efforts to accelerate access to critical medicine for patients with COVID-19 in India.

Malik continued: “Our approval is a significant milestone for Mylan, for the global public health community and, most importantly, for patients who are battling this pandemic. Developing DESREM and bringing it to patients in India with such unprecedented speed is a testament to the strength of our global operations and scientific capabilities and our commitment to serving patients who continue to rely on us during this time. We are proud to continue our work in support of public health in partnership with governments and other stakeholders as we work together in the fight against COVID-19.”

Rakesh Bamzai, President, India and Emerging Markets, said: “The growing global threat of COVID-19 requires a commitment to action by everyone involved in public health. Mylan is cognizant of its responsibility in fighting this pandemic and will leverage its global resources and capabilities including R&D, regulatory, manufacturing and supply chain, while engaging with key stakeholders across the licensed territories to serve the patients in need and further its mission of creating better health for a better world.”

Mylan previously announced a global collaboration agreement with Gilead Sciences for the commercialization of remdesivir in 127 low- and middle-income countries, including India. Mylan has a long-standing history of partnering with Gilead to tackle key public health issues in India and around the world, beginning with expanding access to high quality, affordable HIV/AIDS antiretrovirals and now extending its partnership to include COVID19 treatments. Remdesivir is the tenth medicine licensed to Mylan by Gilead, who signed their first agreement in 2006 for the HIV medicine, tenofovir disoproxil fumarate.

As a leading global pharmaceutical company, Mylan is committed to continue doing its part in support of public health needs. As the situation around COVID-19 continues to evolve, Mylan’s priorities remain protecting the health and safety of its workforce, continuing to produce critically needed medicines, deploying our resources and expertise in the fight against COVID-19 through potential prevention and treatment efforts, and supporting the communities in which we operate.

About Remdesivir
Remdesivir is an investigational new drug developed by Gilead Sciences. Interim results of two large Phase III clinical trials have demonstrated favourable outcomes with Remdesivir. Based on the results, USFDA granted emergency use authorization (EUA) of Remdesivir to treat hospitalized patients with severe COVID-19 in the U.S. In addition, it is recommended for compassionate use in Europe and recently received regulatory approval in Japan, Taiwan and Singapore.

About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high-quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time.


Source: Mylan NV - Click Here

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Sunday 21 June 2020

Hetero announces the approval and launch of first generic ‘COVIFOR’ (Remdesivir) in India for the treatment of Covid-19.

18:38:00 0



Generic drug maker Hetero has received the Drug Controller General of India (DCGI) approval to manufacture and sell its generic version of Gilead’s Remdesivir for the treatment of Covid-19 patients in the country.

The generic version will be marketed under the brand name ‘Covifor’ in India, Hetero said about the product that is being manufactured at its facility in Hyderabad.

DCGI had granted approval for use of Remdesivir in the treatment of suspected or laboratory-confirmed cases of Covid-19 in adults and children, hospitalised with severe symptoms of the disease. 

Covifor (Remdesivir) will be available in 100 mg vial (Injectable) which has to be administered intravenously in a hospital setting under the supervision of a healthcare practitioner, Hetero said.

Sources in the company said since the product has been approved for Emergency Use and for use in hospital / institutional set up only, it will not be retailed through chemists. Instead Covifor will be made available to hospitals treating Covid-19 patients. The supplies are expected to begin in a week.

Each 100 mg vial is likely to be priced between 5,000 and 6,000. The drug is to be administered only after getting the consent of the patients.

“While Glenmark’s Covid-19 drug was made available in the oral form of tablets, Hetero’s drug is being made available in the Injectable form (100mg vial) to be administered intravenously in a hospital setting under the supervision of a healthcare practitioner”.

Approval to launch Covifor (Remdesivir) in the light of increaseing Covid-19 cases in India “can prove to be a game-changer given its positive clinical outcomes,” said Hetero group chairman Dr B. Partha Saradhi Reddy

A significant milestone for Hetero and an important development in India's fight against COVID-19 pandemic. Proud to be the first company to gain DCGI approval for generic drug Remedesivir. It will be marketed under the brand name 'Covifor' for treatment of patients hospitalised with severe symptoms.

For further details, Read more at here 


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Saturday 20 June 2020

Glenmark launches Covid-19 drug FabiFlu for treatment of mild to moderate COVID-19 patients, priced at Rs 103 per tablet

21:18:00 0


Drug firm Glenmark Pharmaceuticals on Saturday said it has launched antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of patients with mild to moderate Covid-19 at a price of about Rs 103 per tablet.

Anti-viral drug Favipiravir approved for treatment of mild to moderate COVID-19 patients will be commercialised full scale in a week, says drug maker Glenmark Pharmaceuticals.

Glenmark’s Fabiflu is the first oral Favipiravir-approved medication for the treatment of COVID-19 and has been launched in few centers. The Drug Controller General of India approved the anti-viral for 'restricted emergency use' for treatment of mild to moderate cases, which accounts for a majority of COVID-19 infections.

" The drug will be available as a 200 mg tablet at a maximum retail price (MRP) of Rs 3,500 for a strip of 34 tablets, Glenmark Pharmaceuticals said.
FabiFlu is the first oral favipiravir-approved medication in India for the treatment of COVID-19, it said in a statement".

It is a prescription-based medication, with recommended dose being 1,800 mg twice daily on day one, followed by 800 mg twice daily up to day 14, it added.
The tablets are being produced by the company at its Baddi facility in Himachal Pradesh. The drug will be available both through hospitals and the retail channel, Glenmark said.

The Mumbai-based firm had on Friday received the manufacturing and marketing approval from the Drugs Controller General of India (DCGI).

Glenmark Life Sciences partners the world’s top 20 generic companies to supply them with a wide range of high-quality, industry-leading Active Pharmaceutical Ingredients (APIs).

We have steadily built scale in our product offerings & reach. Leveraging our state-of-the-art laboratories and manufacturing locations, we supply over 130 molecules to more than 700 customers across 65 countries. From product selection & development to commercialisation, we judiciously blend science, technology and economics to stay ahead of the curve.

In highly-regulated markets, our APIs have enabled several first-to-file offerings by our customers. We have a proven ability to spot and make the most of business opportunities ahead of the competition thus giving an edge to our customers in a competitive market. Glenmark Life Sciences is an independent unit of Glenmark Pharmaceuticals, a 40 year-old integrated, research-driven, global pharmaceutical organization committed to enriching lives.

The company has developed the API and the formulation for FabiFlu through its in-house research and development team, Glenmark said.

“We chose to initiate work on Favipiravir, as it has proven in-vitro activity against SARS CoV2 virus, which is the virus responsible for Covid-19.

“Second is it has a wide therapeutic safety margin for Covid-19 at the dose that we administer,” Glenmark Pharmaceuticals President India Formulations, Middle East and Africa Sujesh Vasudevan said at an online press conference.


More Details About Drug Please View the Video

https://youtu.be/TZWShx8AmqM


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Monday 15 June 2020

Top 25 Pharmacy Colleges in India || NIRF Ranking for Pharmacy Colleges - 2020

23:43:00 0


Top 25 Pharmacy Colleges in India | NIRF Ranking for Pharmacy Colleges - 2020
The National Institutional Ranking Framework (NIRF) was approved by the MHRD (Minister of Human Resource Development). This framework outlines a methodology to rank institutions across the country. Ranking broadly cover “Teaching, Learning and Resources,” “Research and Professional Practices,” “Graduation Outcomes,” “Outreach and Inclusivity,” and “Perception”.

National Institutional Ranking Framework (NIRF), MHRD has released “India Rankings 2020” of Institutions of Higher Education on 11 June 2020. 

Take a look at the top 25 Institutions of Higher Education in the pharma category.
NIRF Ranking (Pharma category):

1. Jamia Hamdard, New Delhi
2. Panjab University,
Chandigarh
3. NIPER,
Mohali, Punjab
4. Institute of Chemical Technology,
Mumbai, Maharashtra
5. NIPER,
Hyderabad, Telangana
6. Birla Institute of Technology & Science,
Pilani, Rajasthan
7. Manipal College of Pharmaceutical Sciences,
Udupi, Karnataka
8. NIPER, Ahmedabad, Gujarat
9. JSS College of Pharmacy,
Ooty, Tamil Nadu
10. JSS College of Pharmacy,
Mysore, Karnataka
11. NIPER, Guwahati, Assam
12. Annamalai University,
Annamalainagar, Tamil Nadu
13. SVKM's Narsee Monjee Institute of Management Studies,
Mumbai, Maharashtra
14. Maharaja Sayajirao University of Baroda,
Vadodara, Gujarat
15. Amrita Vishwa Vidyapeetham,
Coimbatore, Tamil Nadu
16. Birla Institute of Technology,
Ranchi, Jharkhand
17. Nirma University, Ahmedabad, Gujarat
18. NIPER, Raebareli,
Lucknow, Uttar Pradesh
19. S. R. M. Institute of Science and Technology,
Chennai, Tamil Nadu
20. Banasthali Vidyapith,
Banasthali, Rajasthan
21. Amity University Noida,
Gautam Budh Nagar, Uttar Pradesh
22. Poona College of Pharmacy, Pune,
Maharashtra
23. Punjabi University,
Patiala, Punjab
24. Bombay College of Pharmacy,
Mumbai, Maharashtra
25. Delhi Institute of Pharmaceutical Sciences & Research, New Delhi




Pharma Wisdom congratulates all the institutes 
which participated in NIRF rankings.


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Tuesday 12 May 2020

Life after Lockdown. What's the first thing you will do..!!!

22:49:00 0


The government can only hold a lockdown for a certain period of time.  The lockdown will end slowly.  The government also will not show such strictness because the government has made you aware about corona disease, social distancing, hand sanitization etc.

You are also seeing the trauma to be faced when someone gets sick in your neighborhood. Now those who are sensible understand their routine and follow it in future.

🗽 The government cannot and will not guard you 24 hours, 365 days.

👉 The future of you and your family is in your hands.

 🚶  After the lockdown opens, think carefully, leave the house and go to work and do your work as per the rules.

Do you think, after May 17, the Corona will suddenly go away and we will start living like before?

 👉👉👉 No, not at all .

 This virus has taken root in our country and we have to learn to live with it.

How long will the government keep the lockdown?  How long will the exit be banned ?

👉 Now we have to fight this virus ourselves, by changing our lifestyle, by strengthening our immunity.

👍 We have to adapt a life style hundreds of years old.

👅 Eat a pure diet, eat pure spices. Rely on Amla, Aloe vera, Ginger, Pepper, Cloves etc.

👊 Free yourself from the clutches of antibiotics. 

🍎 You have to increase the amount of nutritious food in your life and forget fast foods like pizza, burgers, cold drinks.

🍚 We have to change our utensils, we have to adapt to heavy vessels like brass, bronze, copper from aluminum, steel etc. which naturally eliminate the virus also.

 The amount of milk, curd, ghee will have to be increased in your diet.

🍟 Forget the taste of the tongue and avoid spicy, fried hotel food and street side garbage.

👉  This has to be done for at least the next 7-8 months.  Only then will we be able to survive. And those who do not change will be in trouble.

👉👉👉👉 At least follow this some guideline to protect yourself..
1. Sanitisation (wash your hands with soap for at least 20 to 30 seconds)
2. Do Not Touch Your Face with Unwashed Hands
3. Maintain Social Distance (Keep a distance of at least 1 meter from others)
4. Avoid public places, public transport, malls, markets & functions.
5. Build Immunity through Spices and Other Foods
6. Practice Respiratory Hygiene

👍👍👍👍 Accept this and start implementing them.

 💑 Life is your decision!

🏠 🏠 🏠  STAY HEALTHY... STAY SAFE


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