Page 29 - Usfda

Biocon partner's Cancer drug licence application gets USFDA approval

The application sought approval of Mylan's drug for treatment of patients with metastatic colorectal cancer with fluorouracil-based chemotherapy

USFDA accepts Biocon-Mylan's Avastin biosimilar application for review

The application seeks approval of biosimilar bevacizumab for treatment of patients with metastatic colorectal cancer in addition to other ailments

USFDA accepts proposed biosimilar application by Mylan, Biocon for review

The application seeks approval of Bevacizumab for the first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy

Alembic gets USFDA approval for generic doxycycline hyclate tablets

Doxycycline hyclate tablets are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients

Strides Pharma Science gets USFDA nod for generic anti-bacterial capsules

The product is a generic version of Achromycin V Capsules, 250 mg and 500 mg, of Avet Pharmaceuticals (previously Heritage Pharmaceuticals)

USFDA warnings: Concerns remain even as India fares better than US

According to the USFDA, India accounted for nearly 18 per cent of the active pharmaceutical ingredients (APIs) sourced by the US, while China accounted for 13 per cent

Dr Reddy's gets 1 observation from USFDA after inspecting Hyderabad plant

Earlier, the drug major had said that the US health regulator has issued a Form 483 with two observations after inspecting the facility but later it was issued revised Form 483 with one observation

India scores better than US in regulatory action by USFDA in 2019

From FY15 to FY19, Indian manufacturers received fewer warning letters than Chinese counterparts

Biocon gets two observations from USFDA for Bengaluru-based API plant

Biocon shares on Thurday ended 0.17 per cent up at Rs 299.20 apiece on the BSE.

USFDA issues warning letter to Cipla for Goa manufacturing facility

The company further said that it remains committed to maintain highest standards of compliance and will work closely with the agency to comprehensively address all the observations

Choke in API supplies from China creates huge opportunity for Divi's Labs

Niche capabilities and absence of regulatory overhangs are other key positives

USFDA approves Danish drugmaker Lundbeck's migraine prevention therapy

As Lundbeck enters the crowded market, it hopes to carve a niche for itself through its dosing frequency

Alkem Labs receives two USFDA observations for Baddi facility in Himachal

It notified the company's management of objectionable conditions at the facility

Coronavirus impact: Icra downgrades domestic pharma outlook to negative

According to Icra research, domestic API manufacturers have an inventory of one-two months

USFDA nod to Unit IV a breather for Aurobindo Pharma; share price up 20.4%

Analysts remain positive on Aurobindo's future prospects including the US despite the higher base

USFDA seeks voluntary action at Dr Reddy's Andhra Pradesh facility

Shares of Dr Reddy's Laboratories on Friday closed 0.55 per cent down on the BSE

Granules India gets tentative USFDA nod for Colchicine capsules for gout

The USFDA has tentatively approved the abbreviated new drug application filed by Granules Pharmaceuticals for Colchicine capsules in the strength of 0.6 mg, Granules India said in a filing to BSE.

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