Page 4 - Pharmaceutical Companies

Aurobindo Pharma arm receives FDA nod for Testosterone Cypionate injection

According to research firm IQVIA, the approved product has an estimated market size of $226.8 million for the twelve months ending August 2023

Sun Pharma recalls 144 bottles of anti-depression drug from US market

Sun Pharmaceutical Industries Inc has recalled 144 bottles of a generic anti-depression medicine from the US market due to a manufacturing issue, according to the US Food and Drug Administration (USFDA). The US-based subsdiary of the Mumbai-headquartered drug company initiated the recall for the affected lot of Bupropion Hydrochloride extended-release tablets due to "failed dissolution specifications,", the US health regulator said in its latest Enforcement Report. The affected lot was manufactured at Sun Pharma's Halol-based plant in Gujarat and was distributed in the US by Sun Pharmaceutical Industries Inc, based in Princeton, New Jersy, it said. Bupropion is a medication commonly used to treat depression. The US-based drug maker initiated the voluntary Class III nationwide (US) recall on October 4 this year. As per the US FDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health ...

BDR Pharma launches generic drug for fungal infections at 1/3rd the cost

Zisavel capsules will be available as 100 mg capsules and will be priced at Rs 7,992 for 7 capsules

New treatment: NMC regulations, albeit diluted, likely to be back soon

Agarwal adds that at a CME the speaking doctor is merely sharing his experience of using a particular molecule; never does he mention a particular brand

Cabinet okays Rs 5k cr PRIP scheme to boost research and innovation

The scheme is set to stimulate collaboration between pharmaceutical companies, Cabinet greenlights Rs 5,000 crore PRIP scheme to boost research and innovation institutions, and start-ups

What are generic medicines and how India became the 'pharmacy of the world'

India is the world's largest producer and exporter of generic drugs. But how did it manage to do so? Let us find out here

1 drug sample spurious and nearly 48 substandard in June inspection

Eye-drops made by Indiana Ophthalmics in Gujarat that have been under the scanner also feature in the list

Cognizant seals $800 million deal with California-based Gilead Sciences

Agreement includes renewal and expansion of various IT services over next five years

Dr Reddy's Laboratories forays into new terrain to give 'top-5' aim a shot

Analysts think that these new entries may help the company navigate multiple risks in the Indian branded market

Cipla's US unit recalls 6 batches of bronchospasm inhaler over defect

'The company is initiating a recall in the US due to a market complaint for one single inhaler, where leakage was observed through the inhaler valve,' the pharmaceutical company said in a statement

Facing higher scrutiny, IPA plans monthly meetings with members on quality

Data suggests that Indian sites received fewer OAIs in the first six months of 2023

Quality check: India needs to restore faith in the 'world's pharmacy'

For more than a decade, it has been clear that too many medicine makers in India have not been doing their duty by their customers, here and abroad

Gambia death fallout: Pharma exports to African market slipped 5% in FY23

Medicines put up for retail sales led the decline in exports

Biphore, Zenara gets approval for Cannabidiol that treats neuro disorders

Biophore India Pharmaceuticals has announced that it has received approval from Central Drugs Standard Control Organisation (CDSCO) for manufacturing of Cannabidiol active ingredient in India

USFDA issues Form-483 with 10 observations to Lupin's Pithampur plant

Drug firm Lupin on Thursday said the US health regulator has issued a Form-483 with ten observations after inspecting its Pithampur Unit-2 manufacturing facility. The US Food and Drug Administration (USFDA) inspected the plant from March 21 to March 29, 2023. The inspection closed with issuance of a Form-483 with ten observations, Lupin said in a regulatory filing. "We are addressing the observations comprehensively and will work with the US FDA to resolve these issues at the earliest," it added. As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. In November last year, USFDA had issued Form-483 with eight observations each for product and raw material production centres at Lupin's Mandideep-based manufacturing facility. In October 2022, the drugmaker announced that the US health .

Moderna to hire around 2,000 employees amid mRNA development push

The firm had about 3,900 full-time employees as of Dec. 31, according to a regulatory filing

Court orders jail for 2 Maiden Pharma execs for exporting substandard drugs

The company has denied its drugs were at fault for the deaths in Gambia and tests by an Indian government laboratory found there were no toxins in them

Dr Reddy's acquires Mayne Pharma's USA prescription portfolio for $105 mn

The acquisition will complement DRL's US retail prescription pharmaceutical business with limited competition products

Patent infringement: HC orders Triveni Chemicals to pay Rs 2 cr to Pfizer

Pfizer Inc. and its group companies had filed a suit in the court against Triveni Interchem Private Limited & others accusing the for infringing their patent(IN 218291) for the compound Palbociclib

CRISIL SME Tracker: Strong domestic demand to drive pharma growth in FY23

In December, the domestic pharmaceuticals market grew 10.4 per cent on exceptional growth in both volume sales and prices