Indian Drug Makers

The survey states that the industry is about to witness a redistribution of outsourcing work across several Asian countries, with India and Korea emerging as new powerhouses by 2033

Drug major Cipla expects to commence supplies to the US market from its China facility in the second half of the current fiscal after getting approval from the American health regulator, according to its MD and global CEO Umag Vohra. Addressing shareholders in the company's Annual Report for 2023-24, he noted that the company is working with the USFDA to resolve issues with its various domestic plants. "Although we saw challenging phases with USFDA audits, I am glad to report that our China facility cleared the USFDA audit and is expected to supply to the US by the second half of FY 2024- 25," Vohra said. Sharing updates about other plants, he noted that the facilities of Patalganga and Kurkumbh in India were also cleared with a VAI (voluntary action indicated). "Our Goa site was issued observations and our Indore plant is currently being remediated. Finding resolution for these regulatory issues continues to be our top priority," Vohra said. The company has worked extensively to

Cipla advanced its board meeting to January 22 to approve its results for the quarter and nine months ended December 31, 2023, to avoid confusion following an alleged social media leak

Pharma major Lupin Ltd on Thursday said it has received approval from the US health regulator to market its generic Febuxostat tablets, indicated for the chronic management of hyperuricemia in adult patients with gout. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Febuxostat tablets of strengths 40 mg and 80 mg, a generic equivalent of Uloric tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals USA, Inc, Lupin said in a regulatory filing. The product will be manufactured at the company's Pithampur facility in India, it added. The company said Febuxostat tablets of strengths 40 mg and 80 mg are indicated for the chronic management of hyperuricemia (elevated serum uric acid level) in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol; who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Febuxostat tablets had estimated annual sales of U

BDR stated since BDENZA is in liquid form, they can't quantify how lower it is compared to its counterparts in the market as they are present in solid form (tablet/capsule)

Launching a new drug in India takes up to four years longer than in markets such as the United States and the European Union, said the pharma lobby

Taking suo moto cognizance of the drug menace, the Rajasthan High Court on Saturday issued notices to the central and state governments seeking affidavits detailing existing mechanisms to control the "unregulated" production of tablets and syrups containing psychotropic substances. The court also sought information on any mechanisms in place to regulate the distribution of such tablets and syrups to dealers, distributors, and retail pharmacists. The matter came up during a bail application hearing on Saturday, when Justice Farjand Ali took note of a commercial quantity of medicinal drugs allegedly seized from the petitioner. Justice Ali expressed concern over the heavy sale and consumption of tablets, medicinal drugs, and syrups containing psychotropic substances. The court questioned the unregulated operation of city drugstores and called for the identification of sources involved in illegal distribution. The court also noted that despite arrests and detention of drugstore employ

"Regular assessments are conducted to evaluate the stock positions at various levels, from central warehouses to peripheral health institutes," it said

Indian drugs regulators have taken action against 105 pharmaceutical companies after a risk-based inspection and audit of manufacturing plants, the health minister said on Tuesday

The purpose of this World Drug Day 2023 campaign is to spread awareness of the significance of treating people using drugs with respect and compassion

The new rule highlights how governments are reassessing their reliance on India's $42 billion pharmaceutical industry since the contamination came to light last year

Objective of drug regulation is to ensure safety, efficacy, and quality of drugs

The industry is divided on the issue of phasing out codeine-based cough syrups, which are used by many as intoxicants

Leading homegrown drug makers Aurobindo Pharma and Sun Pharmaceutical Industries are recalling different products in the US market due to deviation from standard manufacturing norms.

The Subject Expert Committee in its meeting recommended the use of this drug to treat high-risk patients.

The government is engaging with the drug manufacturers to ramp up the production of an antifungal drug used for the treatment of mucormycosis, says Chemicals and Fertilizers Ministry

The government on Wednesday said that all seven manufacturers of remdesivir in the country have been asked to ramp up production to full capacity by next week.

Recovery slow, top drug firms post muted growth in February

Domestic players will be free to price it; Dutch firm Mylan also to make the drug in India; no royalty for Gilead as yet

Cipla gets nod for drug from USFDA earlier than expected; Lupin in fray