USFDA approves Dr Reddy Lab’s UK plant after seven-month scrutiny

USFDA approves Dr Reddy Lab’s UK plant after seven-month scrutiny

2018-04-24T12:17:22+00:00 On

The United States Food & Drugs Administration has closed its audit of the UK manufacturing plant of Dr Reddy’s Laboratories, the Indian pharmaceutical company said. In September last year, the company had announced that the US FDA issued a Form 483 with…

Lupin gets USFDA nod for generic version of Valeant’s Xenazine

Lupin gets USFDA nod for generic version of Valeant’s Xenazine

2018-04-23T12:40:08+00:00 On

Pharma major Lupin said it received final approval for to launch a generic version of Valeant Pharmaceuticals’ Xenazine in the US. Tetrabenazine Tablets, 12.5 mg and 25 mg, has annual sales of approximately USD 288.1 million in the US, according to IQVIA….

Fortis Healthcare sets up expert committee to evaluate all bids

Fortis Healthcare sets up expert committee to evaluate all bids

2018-04-19T17:14:55+00:00 On

Hospital chain Fortis Healthcare said it has set up a special committee to evaluate the bids submitted by various parties to invest money into the company. It said the company has received binding offers from the Manipal – TPG consortium and the…

Zydus Cadila gets USFDA nod for NSAID Diclofenac Sodium

Zydus Cadila gets USFDA nod for NSAID Diclofenac Sodium

2018-04-19T09:55:39+00:00 On

Pharmaceuticals maker Zydus Cadila said it received the final approval from the USFDA to market inflammation solution Diclofenac Sodium in the country. Diclofenac Sodium topical solution, 1.5%, is a non-steroidal anti-inflammatory drug (NSAID) used for symptomatic treatment of osteoarthritis of the knee….

Munjals and Burmans sweeten their offer for Fortis Healthcare, drop conditions

Munjals and Burmans sweeten their offer for Fortis Healthcare, drop conditions

2018-04-19T09:08:58+00:00 On

Embattled hospital chain Fortis Healthcare said it received an improved combined offer from the Munjals of Hero MotoCorp and the Burmans of Dabur Ltd. Under the revised terms, the investors are willing to invest Rs 1,500 cr, against the Rs 1,250 cr…

Lupin gets tentative USFDA approval for billion-dollar testosterone drug

Lupin gets tentative USFDA approval for billion-dollar testosterone drug

2018-04-17T16:00:05+00:00 On

India-based pharma major Lupin said the US drugs regulator has granted it a conditional, or tentative, approval to sell a generic version of the popular testosterone gel AndroGel. AndroGel, made by AbbVie Inc, is a big-selling drug with annual sales of well…

Strides Shasun launches generic version of Merck’s allergy drug in US

Strides Shasun launches generic version of Merck’s allergy drug in US

2018-04-12T12:14:38+00:00 On

Pharma manufacturer Strides Shasun said it received approval from the United States Food and Drug Administration to sell a generic version of Merck’s Periactin tablets. The US market for Cyproheptadine Hydrochloride Tablets is approximately USD 20 Million, according to IQVIA, the company…

ICRA downgrades Fortis Healthcare for missing loan repayment

ICRA downgrades Fortis Healthcare for missing loan repayment

2018-04-11T12:14:11+00:00 On

Credit rating agency ICRA Ltd downgraded Fortis Healthcare’s outstanding debt obligations of Rs 1,170 cr after the company missed the repayment of a loan. The company’s long term rating for Rs 250 crore non-convertible debenture programme, Rs 105 crore fund-based limits, and…

Biocon, Mylan get approval for glargine insulin in Europe, Australia

Biocon, Mylan get approval for glargine insulin in Europe, Australia

2018-03-28T08:54:31+00:00 On

Pharmaceutical manufacturer Biocon and its partner Mylan received marketing approval for their glargine insulin product Semglee in European Union and Australia, marking the first biosimilar approval for the partnership in Europe. Biosimilars are drugs that mimic or imitate the actions of natural…

Suven Life Sciences gets patents in Norway, Korea & Singapore

Suven Life Sciences gets patents in Norway, Korea & Singapore

2018-03-22T10:56:15+00:00 On

Suven Life Sciences Ltd said it was granted one patent each from Norway, South Korea and Singapore for drugs for the treatment of neurodegenerative diseases. The company said the patents relate to selective 5-HT 6 and 5HT 4 compounds, which are being…

USFDA finds objections on inspecting Alembic Pharma’s Panelav plant

USFDA finds objections on inspecting Alembic Pharma’s Panelav plant

2018-03-21T09:33:18+00:00 On

Alembic Pharmaceuticals said it has been issued with a Form 483 by the US Food and Drug Administration after the drug regulator conducted a routine inspection of its formulations facility in Panelav in Gujarat. Form 483 is issued to firm management at…

Cipla dismisses concerns over FDA observations on Goa plant

Cipla dismisses concerns over FDA observations on Goa plant

2018-03-20T13:09:41+00:00 On

Pharma major Cipla dismissed concerns about adverse observations by the US Food and Drug Administration on one of its manufacturing plants in Goa. The Goa plant is one of the company’s largest manufacturing locations for exports, and the observations could affect the…

Lupin launches generic version of Bayer’s birth control pill Safyral

Lupin launches generic version of Bayer’s birth control pill Safyral

2018-03-13T14:06:09+00:00 On

Pharma major Lupin said it launched a generic version of Bayer’s birth control drug Safyral tablets in the US. The company had received FDA approval for the launch in December. The tablets has annual sales of approximately USD 22 million in the…

Maharashtra lifts ban on Jubilant LIfe Sciences’ alcohol production

Maharashtra lifts ban on Jubilant LIfe Sciences’ alcohol production

2018-03-07T08:24:11+00:00 On

Pharma company Jubilant Life Sciences said the government of Maharashtra has stayed the order passed by state excise commissioner stopping the production of alcohol at one of its plants in the state. On March 3, the commissioner had canceled the company’s licenses…

Glenmark reveals encouraging data from hay fever study

Glenmark reveals encouraging data from hay fever study

2018-03-06T09:20:50+00:00 On

Glenmark Pharmaceuticals reported encouraging clinical trial data from the study of its drug Ryaltris for hay fever or seasonal allergic rhinits. “Results of these robust studies demonstrates that consistent, significant relief from symptoms may be rapidly achieved and sustained with Ryaltris,” said…

Lupin launches testosterone solution in the US

Lupin launches testosterone solution in the US

2018-02-27T09:48:39+00:00 On

Pharma major Lupin said it has launched a testosterone topical solution in the US for males suffering from the deficiency of the hormone. Lupin’s Testosterone Topical Solution is the generic equivalent of Eli Lilly and Company’s Axiron solution, Testosterone Topical Solution, 30…

Strides Shasun launches OTC version of ulcer drug Ranitidine in the US

Strides Shasun launches OTC version of ulcer drug Ranitidine in the US

2018-02-26T09:48:07+00:00 On

Pharma major Strides Shasun said it has decided to launch the ‘over the counter’ version of ulcer drug Ranitidine in 150 mg dosage in the US markets immediately. Strides Shasun is already a key player in the US Ranitidine market with 32%…

Fortis Healthcare gets notice from Registrar of Companies

Fortis Healthcare gets notice from Registrar of Companies

2018-02-22T16:14:28+00:00 On

Hospital chain Fortis Healthcare said it received a notice from the Punjab and Chandigarh office of Registrar of Companies asking for information. The company did not clarify what the information was related to, but it is likely that it is related to…