Page 4 - Granules India

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.

Granules India divests entire stake in JV Biocause Pharmaceutical

Shares of Granules India Ltd were trading at Rs 146 a piece on BSE

Granules India recalls over 23 million ranitidine tablets from US market

Ranitidine tablets are used to treat ulcers of the stomach and intestines

Granules India hits fresh 52-wk high on reports of PE firms eyeing stake

The Blackstone Group, KKR & Co, Apax Partners, Advent International and Bain Capital are among the leading global PE companies in early-stage discussions to acquire Granules India, as per reports

Granules India trades near 52-wk high, surges 18% after PAT jumps 59% in Q2

While operational income grew 20 per cent at Rs 700 crore as against Rs 581 crore in the year ago quarter, Ebitda (earnings before interest, tax, depreciation and amortization) margin expanded 322 bps

Granules India up 7% on USFDA nod for generic Methylergonovine tablets

The stock rallied 7% to Rs 104 after the company said Granules Pharmaceuticals Inc., a wholly owned subsidiary of the company, received USFDA approval for generic Methylergonovine tablets.

Pharma major Granules India to invest $84 million in expansion

Investment will be backed by IFC, which has three previous exposures to the company

Granules India dips 10% on 11 observations from Portugal authority

The regulator had detected nonconformities in the good manufacturing practices system

Granules India dips over 10% as Telangana facility gets 11 observations

The stock dipped nearly 11% to Rs 97.80 on BSE in early morning trade on back of heavy volumes

Granules India Q2 net up 26% at Rs 40.83 crore

The company's revenues stood at Rs 363.81 crore, an increase of 3% over Rs 352.9 crore in the year ago period

Granules gets USFDA nod for anti-inflammatory drug

Shares of Granules India Ltd were trading 0.62 per cent higher at Rs 121 on BSE

Granules Q1 net profit up 36% at Rs 39 crore

Total income from operations grew 6.56% to Rs 343.73 crore in the quarter from Rs 322.56 crore in the year ago period

Granules acquires 12.5% stake in USpharma

The company did not disclose the details about exact payout being made towards this stake buy, citing confidentiality agreement

Granules India gains on product in-licensing pact with US firm

The company's US arm has exclusive agreement with USpharma Windlas, LLC for product in-licensing

Granules acquires exclusive product rights from US pharma company

Windlas through its subsidiaries holds Abbreviated New Drug Applications (ANDAs) for Fingolimod, Prasugrel, Dronedarone and Lurasidone

Granules India gets establishment inspection report from USFDA

For the inspection done at the company's Jeedimetla plant in Telangana