Pharma News

Zydus Lifesciences on Thursday said it received final approval from the US Food and Drug Administration (FDA) to manufacture and market Metoprolol Tartrate tablets in dosages of 25 mg, 50 mg, and 100 mg.

Metoprolol is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication is also used to treat chest pain (angina) and improve survival chances after a heart attack. Metoprolol belongs to a class of drugs known as beta-blockers, according to a statement released by Zydus on Thursday. It works by blocking the action of certain natural chemicals in body, such as epinephrine, on the heart and blood vessels. This effect lowers the heart rate, blood pressure, and strain on the heart.

The drug will be manufactured at the group’s formulation manufacturing facility in Baddi, Himachal Pradesh, Zydus said.
Metoprolol Tartrate tablets of dosage — 25 mg, 50 mg, and 100 mg — had annual sales of USD 45.2 million in the United States, according to IQVIA MAT of the month, February 2023.

The group now has 364 approvals and has so far filed over 440 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY2003-04.

Zydus Lifesciences Limited, formerly known as Cadila Healthcare, is an Indian multinational pharmaceutical company headquartered in Ahmedabad, which is primarily engaged in the manufacture of generic drugs. According to Wikipedia, the company ranked 100th in the Fortune India 500 list in 2020.

Licenses of 18 pharma companies have been cancelled for manufacturing spurious medicines following an inspection by the Drugs Controller General of India (DCGI) on 76 companies across 20 states, ANI reported on Thursday. Action has been taken on 70 companies in Himachal Pradesh and 45 in Uttarakhand and 23 in Madhya Pradesh during the government crackdown on companies manufacturing spurious medicines, ANI reported.

ANI has accessed the list of companies that manufactured spurious medicines.
According to a list of accessed by ANI, most of the companies against whome action has been taken are registered in Uttarakhand and Himachal Pradesh.

The license of Himalaya Meditek Pvt Ltd registered in Dehradun was suspended for manufacturing with immediate effect from December 30, 2022 and permission for it to manufacture 12 products was cancelled on February 7, this year.
Showcause and stop manufacturing notice was issued to Shri Sai Balaji Pharmatech Pvt Ltd from Baddi, Himachal Pradesh. After verification of compliance by Drug Inspectors, the stop-manufacturing order was revoked.

EG Pharmaceuticals, Vill Mandhala, Teh Kasauli, Dist Solan (Himachal Pradesh) was also issued show cause notice and the stop manufacturing order was revoked after verification of compliance.

Athens Life Sciences, Mauza Rampur Jattan, Nahan Road Kala Amb, Distt Sirmour 173030 (Himachal) was only issued show cause notice.

A warning was issued to Laborate Pharmaceuticals India Ltd,(Unit -II), Rajban Road, Nariwala, Paonta Sahib (Himachal) and a show cause was issued.

GNB Medica Lab, in Himachal’s Solan, has been asked to stop manufacturing in tablets, capsules, dry syrups (Beta-Lactam), Injectables (Liquid Injection -vials, ampoules and PFS) Sachet and Protein Powder (General Section) and show cause notice issued as well as compliance sent to drug inspectors for verification.

Gnosis Pharmaceuticals Pvt Limited, Nahan Road, Village Moginand, Kala Amb, Sirmour (Himachal) was given show cause and stop manufacturing notices for Cosmetic Manufacturing.

Nestor Pharmaceuticals Limited registered in Faridabad was given a show-cause notice on January 30 this year. The firm was re-inspected post submission of compliance. It was strictly warned with a direction to comply with the provisions of Schedule M of the Drugs and Cosmetics Act and the Rules framed thereunder.

The massive crackdown on pharma companies across the country related to the manufacturing of spurious medicines is still underway.

Following a warning from the US Food and Drug Administration to “not to purchase or use EzriCare Artificial Tears due to potential contamination” the Central Drugs Standard Control Organization (CDSCO) under the Union Health ministry and the Tamil Nadu State Drug Controller have launched an investigation into the pharma firm producing this eyedrop, a report familiar with the situation said on Friday.

“Teams from CDSCO and TN State Drug Controller, comprising three officials, are on their way to the manufacturing plant located near Chennai. It’s a contract manufacturing plant supplying through others to the US market. This specific drug is not sold in India,” said the source. FDA has also restricted the imports of products manufactured by Global Pharma Private Healthcare Limited.

“The import alert prevents these products from entering the United States,” FDA said in a statement, adding “FDA is warning consumers and health care practitioners not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. Using contaminated artificial tears increases the risk of eye infections that could result in blindness or death.”

The over-the-counter products, manufactured by Global Pharma Healthcare Private Limited, are intended to be ‘sterile’, the FDA noted.

Global Pharma has initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears, the source informed further.

The FDA also stated that the recall was recommended due to the company’s current good manufacturing practise (CGMP) violations, which included a lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles without an adequate preservative), and a lack of proper controls regarding tamper-evident packaging.

On the fringes of the World Economic Forum, Albert Bourla, CEO of the US-based pharmaceutical company Pfizer, was confronted with a series of challenging questions concerning the efficacy of its Covid vaccine, but he repeatedly disregarded the questions, and a video of it has gone viral. A Rebel News journalist was spotted asking the Pfizer CEO a series of difficult questions. He questioned the CEO, among other things, why the firm kept the knowledge that its vaccination did not stop viral transmission a secret. The Pfizer executive time and again evaded these inquiries, only to answer “Thank you very much” and “Have a wonderful day”.

The journalist can be heard saying in the film, “You (Pfizer) claimed it was 100% effective, then 90%, then 80%, then 70%, but we now know that the vaccinations do not prevent transmission. Why are you keeping something a secret?”

Even though he did not receive a response, the journalist continued to pursue the Pfizer CEO. In another query, he was heard questioning whether it was time to apologise to the globe and repay nations who purchased vaccines that did not work.

Back in the early days of the immunisation campaign, the US-based pharmaceutical company Pfizer requested an indemnity bond to protect it from legal lawsuits if the vaccine had any unwanted effects.

India’s minister for state for information and technology Rajeev Chandrasekhar, attaching the video of the Pfizer CEO’s uneasy encounter with the reporter at Davos, tweeted, “Just to remind all Indians, that Pfizer tried to bully Govt of India into accepting conditions of indemnity.”

The minister went on to criticise Rahul Gandhi, P Chidamabaram, and Jairam Ramesh of the Congress, stating that the trio continued to promote the case for providing foreign vaccinations in India.

“People are surprised that only three vaccines have been made available in India: Covishield, Covaxin and Sputnik Of the three, you can write off Sputnik because only a small quantity was imported in the initial days,” Congress veteran Chidambaram had tweeted on December 27, 2021.

“We are left with 2 vaccines thanks to the PROTECTIONIST policy of the Modi Government Pfizer, Moderna and other WHO-approved vaccines are kept out of India on one pretext or other Which is why we don’t have enough vaccines to administer 2 doses to the 94 crore adult population.”

Notably, India’s Covid immunisation campaign was mostly supported by locally made vaccines.

Lupin stated on Tuesday that the United States Food and Drug Administration (US FDA) has approved its abbreviated new drug application (ANDA), Prasugrel tablets for 5 mg and 10 mg, which is a generic counterpart of Cosette Pharmaceuticals Inc.’s Effient tablets, 5 mg and 10 mg.

According to a statement from Lupin, the product would be manufactured in the company’s Goa site.
According to IQVIA, prasugrel tablets of 5 mg and 10 mg have expected annual sales of USD 18 million in the United States.

A release said Lupin, headquartered in Mumbai, develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific, Latin America, Europe, and Middle East regions.

Lupin said it has 15 manufacturing sites, seven research centres, more than 20,000 professionals working globally, and has been consistently recognised as a ‘Great Place to Work’ in the biotechnology and pharmaceuticals sector.

The Sun Pharmaceuticals Halol factory in Gujarat was placed under import alert on Thursday by the US Food and Drug Administration.

The Import Alert implies that until the facility complies with CGMP standards, all future shipments of products made at this facility may be denied admission to the US market, according to a statement from the pharmaceutical company to the stock exchanges. The USFDA’s Current Good Manufacturing Practices regulations are referred to as CGMP. Systems for ensuring proper manufacturing process and facility design, monitoring, and control are provided by CGMPs.

14 of the company’s products are exempt from this import alert according to the USFDA, subject to some restrictions.

The statement claims that, with the 14 excluded goods indicated above, deliveries to the US market from the Halol facility accounted for around 3% of the company’s consolidated revenues for the year ending March 31, 2022.

The firm declared that it would take all necessary measures to address these problems and make sure that the regulator was wholly happy with the company’s corrective action. It also indicated that it would continue to collaborate with the USFDA.

It declared that it remained dedicated to providing CGMP-compliant goods to its clients and patients around the world.