Page 18 - Usfda

Pharma industry poised to beat FY19 exports despite strict US regulations

April-December exports rise 11.5%; estimates peg FY20 numbers at $22 billion

Granules India arm gets USFDA nod for generic version of Roche antiviral

Drug firm Granules India Ltd on Wednesday said its foreign arm has received approval from the US health regulator for Valganciclovir hydrochloride oral solution, an antiviral medication. "The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc, a-wholly owned foreign subsidiary of Granules India Ltd for Valganciclovir hydrochloride for oral solution, 50 mg/ml," the company said in a regulatory filing. It is bioequivalent to the reference listed drug product (RLD) -- Valcyte for oral solution, 50 mg/m, of Roche Palo Alto LLC, the filing said. Valganciclovir hydrochloride solution is an antiviral medication used to treat cytomegalovirus infections. Shares of Granules India were trading at Rs 153 a piece on BSE, up 4.83 per cent from the previous close.

USFDA completes inspection of Cadila Healthcare's Ahmedabad facility

Shares of Cadila Healthcare closed at Rs 264.05 per scrip on the BSE, up 1.46 per cent from its previous close

FIIs rejig sectoral exposure ahead of Budget; pick pharma stocks, drop IT

Investors bet in anticipation of easing of regulatory issues in the pharma segment

Alembic Pharma's Aleor Dermaceuticals gets USFDA nod for generic product

Alembic now has a cumulative total of 118 ANDA approvals from the USFDA

Alembic Pharma gets final nod from USFDA for infection treatment drug

Azithromycin tablet is a macrolide antibacterial drug indicated for mild to moderate infections

Torrent Pharma Q3 result: PBT rises 16% to Rs 319 crore, revenue declines

US business down by 22% in third quarter, India revenues grow by 5%

USFDA issues Form 483 with 5 observations to Biocon's Bengaluru facility

Biocon Ltd on Monday said the US health regulator conducted a pre-approval inspection and good manufacturing practice (GMP) examination of the API manufacturing facility and has issued a Form 483, with five observations. As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. "The US Food and Drug Administration (FDA) conducted a Pre-Approval Inspection (PAI) and GMP inspection of the Active Pharmaceutical Ingredients (API) manufacturing facility of Biocon Ltd," Biotechnology major said in a filing to BSE. At the conclusion of the inspection of the Bengaluru facility, which took place between January 20-24, 2020, the agency issued a Form 483, with five observations, the filing said. "We will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of ...

Tipping point: Should you bet on the revival of pharmaceutical funds?

Whenever the domestic economy is not doing well, smart money shifts to export-oriented sectors like pharma

Alembic gets USFDA nod for Tizanidine hydrochloride capsules for spasticity

Drug firm Alembic Pharmaceuticals on Wednesday said it has received final nod from the US health regulator for Tizanidine hydrochloride capsules, used to treat spasticity. "The company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg," the drug firm said in a regulatory filing. Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important. "The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zanaflex Capsules, 2 mg, 4 mg, and 6 mg, of Covis Pharma BV," the filing said. Tizanidine hydrochloride capsules, 2 mg, 4 mg, and 6 mg have an estimated market size of USD 28 million

Q3 results preview: US regulatory overhang on earnings of pharma firms

The US is Indian pharma's largest export market and Indian drugmakers account for a little over 30 per cent of generic drugs sold in that country

Uptick in domestic segment, biz growth continue to drive Ipca Laboratories

Further rerating of stock will hinge on USFDA resolution

US experts urge new talc testing standards amid asbestos worries

The most significant recommendation from the panel of government experts is that mineral particles found in talc products small enough to be drawn into lungs should be counted as potentially harmful

Pharma firms plan awareness drive to battle cancer scare in antacid

Indian companies have also been hit in their global business.

GSK's HIV venture fails to get USFDA approval for once-a-month injection

ViiV Healthcare received a complete response letter from the Food and Drug Administration, which cited "chemistry manufacturing and controls," according to a statement from the HIV unit

Cadila gains after USFDA concludes plant inspection with no observations

The United States Food and Drug Administration (USFDA) inspected the company's topical manufacturing facility in Ahmedabad during December 16-20, 2019, the drug firm said in a BSE filing.

FDA observation, forensic audit by Sebi may keep Sun Pharma under pressure

Halol plant observations add to worries on the extent of upsides from specialty drugs

HCG becomes first hospital in India to digitise histopathology diagnosis

Digital diagnosis is now the default diagnosis of the lab for surgical pathology and 100% of FFPE slides are digitally scanned into high-resolution digital images

Expansions, clean track record helping Divi's Labs tap new opportunities

The current margin pressure will also get mitigated by tax benefits and operational efficiencies

Biocon, Mylan get USFDA nod for pegfilgrastim from new Bengaluru facility

Biocon Biologics, through its partner Mylan, has commercialised three of its co-developed biosimilars in developed markets like the US, Canada, the European Union and Australia.