Glenmark, Torrent Pharma ink licensing % to co-marketplace diabetes drug in India

by Lionel Casey

On July eleven, Glenmark Pharmaceuticals and Torrent Pharmaceuticals said they had entered right into a licensing agreement to co-market the diabetes drug Remogliflozin Etabonate in India.

“Under the terms of the agreement, Glenmark will receive an advance charge, license costs, and royalties from Torrent for the non-specific sub-license rights.

“Glenmark will manufacture and deliver Remogliflozin while Torrent will market the drug under its own trademark, ‘Educator,’ in India,” Glenmark Pharma stated in a regulatory submission.

The agency did not reveal the economic information for the licensing settlement.

Glenmark Pharma said in April 2019 that it had acquired approval from the Drugs Controller General of India (DCGI) for Remogliflozin Etabonate after efficaciously completing segment-3 clinical trials, in which the drug tested maximum efficacy and protection profile in a head-to-head comparison with Dapagliflozin.

diabetes

Subsequently, Glenmark released Remogliflozin, indicated for the treatment of Type 2 diabetes mellitus in adults, under the emblem names ‘Remo’ and ‘Rozen’.

“The burden of diabetes in India is growing at an alarming rate, and via this collaboration, we intend to enhance access to the present-day, novel, and globally researched sodium-glucose co-transporter-2 (SGLT2) inhibitor by presenting a powerful, high-quality, and global-class remedy option to patients in India,” Glenmark Pharmaceuticals President, India Formulations, Middle East and Africa Sujesh Vasudevan stated.

“This partnership may also lay the foundation for a long-time collaboration with Torrent for Remogliflozin in phrases of its extra line extensions and further medical development,’ he delivered.
Dhruv Gulati, Executive Director (India & ROW), Torrent Pharma, said, “The drug will augment the Type 2 Diabetes Mellitus treatment armamentarium in the u. S., This partnership could be an essential step closer to enhancing entry to the growing wishes of diabetic patients.”

Johnson & Johnson’s well-known baby shampoo no longer includes chemical formaldehyde; re-checks did use the relevant tablets laboratory has said.

The Central Drugs Laboratory in Kolkata performed tests on two special masses of the J&J child shampoo after the employer contested the Rajasthan Drugs Control Organisation (RDCO), which claimed to have discovered formaldehyde within the shampoo.

The RDCO’s website posted the effects of the exams accomplished using Central Drugs Laboratory, which said that “the sample does now not contain formaldehyde” in each lot.

When contacted, a Johnson & Johnson spokesperson told PTI: “We are thrilled with the Rajasthan FDA’s realization, which confirms that Johnson’s Baby Shampoo does now not contain formaldehyde.”

The outcome reaffirms the agency’s testing and the longstanding assurance it gave that its toddler shampoo does now not incorporate formaldehyde or any formaldehyde-liberating substances, the corporation said.

“Importantly, this is the result of the appellate laboratory, following a Justice of the Peace Court docket order for re-testing, and overrules an earlier check result that changed into faulty,” the spokesperson said.

The agency said that nothing is more vital to Johnson & Johnson than the protection of people who use its products. The company’s quality guarantee system is rigorous, meeting or exceeding standards in every country where its products are offered.

In a June 3, 2019, order to all Drug Control Officers of Rajasthan, the RDCO said that, in accordance with the Kolkata laboratory’s check record, samples of Johnson & Johnson’s infant shampoo, 100 ml, and 50 ml, no longer comprised formaldehyde.

According to professionals, formaldehyde can cause most cancers in humans.

On March five, 2019, the Rajasthan Drugs Control Organization reported formaldehyde in samples of two batches of baby shampoo manufactured by Johnson & Johnson in India.
The corporation rejected the finding and said its merchandise no longer comprises formaldehyde or any component that is able to free it. It wondered what the Rajasthan drug controllers declared and what the checking-out approach brought about the outcomes.

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