Pharmaceutical Companies

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

Torrent Pharma Q3 net profit up 14% to Rs 283 cr; interim dividend declared

Torrent Pharma on Wednesday said its consolidated net profit increased by 14 per cent to Rs 283 crore in the third quarter ended December 31, 2022. The drug firm had reported a net profit of Rs 249 crore in the October-December period of previous fiscal. Net sales increased to Rs 2,459 crore in the quarter under review as against Rs 2,092 crore in the year-ago period, the company said in a regulatory filing. The company's board, which met on Wednesday, declared an interim dividend of Rs 14 (280 per cent) per share of Rs 5 each. On Wednesday, shares of the company ended 1.86 per cent down at Rs 1,557.50 apiece on the BSE.

WHO issues a 'medical product alert' for Marion Biotech cough syrup

The WHO has said Marion Biotech had not provided guarantees to them on the safety and quality of these products

Sun Pharmaceuticals launches drug for advanced breast cancer patients

Sun Pharmaceutical on Wednesday launched a novel anti-cancer drug Palbociclib under the brand name of Palenotm for patients with advanced breast cancer.

Around 21 API projects come up under the PLI scheme, shows data

These units have an installed capacity of 33,895 tonnes

Granules India ties up with Greenko Group for 'green' pharma zones

As a part of the partnership, Granules and Greenko ZeroC will develop and promote state-of-the-art Integrated Green Pharmaceutical Zones (GPZ) with first collaboration in Kakinada, Andhra Pradesh

Domestic, semi-regulated markets to drive pharmaceutical industry's growth

High raw material prices to put pressure on margins

Hyderabad-based drug major Hetero prices Paxlovid generic at $60 per course

Generic version of Pfizer's Covid antiviral treatment would be exported for $70

Alembic Pharma gets USFDA nod for generic drug to treat breast cancer

Alembic Pharmaceuticals on Monday said it has received final approval from the US health regulator for its generic Fulvestrant injection used in treatment of breast cancer. The approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA), Fulvestrant injection of strength 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, the company said in a statement. The approved injection is therapeutically equivalent to the reference listed drug product (RLD), Faslodex Injection, of AstraZeneca Pharmaceuticals LP, it added. Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of breast cancer, the company said. For 12 months ended September 2022, Fulvestrant injection, 250 mg/5 mL, had an estimated market size of USD 71 million, the company said citing IQVIA data.

Pharma exports likely to touch all-time high of $27 bn in FY23 riding on EU

Better figure expected despite global headwinds; India has so far exported pharma products worth $16.57 bn during April-November this year

Lupin set to gain market share in US flu season; shares up 6% in 2 sessions

The stock has underperformed peers and the benchmark over the past year

Maiden Pharma cough syrup row: Gambian Parliament seeks legal action

WHO, however, said samples tested in Ghana and Switzerland were found to be contaminated

Gambia panel seeks Indian manufacturer's prosecution for cough syrup deaths

A parliamentary committee in The Gambia has recommended prosecution of an Indian manufacturer of cough syrups suspected of causing the deaths of at least 70 children in the West African country

Indian pharma sector set for 'volume to value leadership' journey in 2023

Reinvent and innovate will be the key mantra for the Indian pharma industry in the New Year as the 'pharmacy of the world' looks to move from volume to value leadership

USFDA issues warning letter to Glenmark Pharma for lapses at Goa plant

The US health regulator has pulled up drug maker Glenmark Pharmaceuticals for manufacturing lapses, including failure to establish required laboratory control mechanisms, at its Goa-based manufacturing plant. In a warning letter addressed to Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha, the US Food and Drug Administration (USFDA) pointed out various lapses at the company's Bardez-based facility in Goa, which produces drug formulations. The US Health regulator noted that the "warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals". It further said: "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated..." The USFDA inspected the manufacturing facility from May 12, 2022, to May 20, 2022. In the warning letter, the US health regulator pointed out the company's failure "to ...