Suven Life Sciences wins 2 patents in Australia, 1 in Singapore

Pharma player Suven Life Sciences said it received two patents from Australia and one from Singapore for new drugs that can be used for the treatment of disorders associated with Neurodegenerative diseases. “The granted patents include the class of selective H3 Inverse agonists and 5HT 6 compounds respectively and are being developed as therapeutic agents […]

Strides Shasun, Apotex to merge Australian ops to create biggest generics player

Pharma player Strides Shasun said it has agreed in principle to merge its Australian business with the Australian operations of peer Apotex. Both have substantial businesses in Australia; Strides under the Arrow brand and Apotex under its primary brand. The merger will enable Strides, through the merged business, to become the leading player in the […]

Malaysia’s IHH Healthcare releases details of Rs 4,000 cr bid for Fortis Healthcare

Malaysia’s IHH Healthcare has come out with a binding offer to invest Rs 650 cr in Fortis Healthcare, and follow it up with Rs 3,350 cr after conducting three weeks of due diligence on the company’s account books. The move competes with offers such as the Rs 1,500 cr offer from the combined team of […]

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

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 three observations regarding operations at the pharmaceutical drug manufacturing plant at Mirfield, leading […]

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

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. The tablet is indicated for the treatment of chorea, or involuntary movements associated […]

Fortis Healthcare sets up expert committee to evaluate all bids

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 Munjal & Burman family offices, while non-binding expressions of interest has been received […]

Zydus Cadila gets USFDA nod for NSAID Diclofenac Sodium

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. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad, the […]

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

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 promised earlier. The upfront investment has been increased to Rs 750 crores, while […]

Fortis Healthcare says no risk of bankruptcy

Fortis Healthcare confirmed a report that the company had availed of a three-year loan of Rs 160 cr, but denied that it was done to avoid bankruptcy. “We wish to confirm that the Company has availed a secured financing facility upto Rs. 160 crore from RattanIndia Finance Private Limited on March 29, 2018.. We would […]

Lupin gets tentative USFDA approval for billion-dollar testosterone drug

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 over $1 bln. AbbVie, which has patents valid up to 2020 on the […]

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

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 said. The drug is an antihistamine used to relieve allergy symptoms such as […]

ICRA downgrades Fortis Healthcare for missing loan repayment

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 Rs 195 crore term loans has been revised from  BBB- to C. It […]

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

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 proteins or enzymes in the body, such as insulin. Glargine insulin, which is […]

Suven Life Sciences gets patents in Norway, Korea & Singapore

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 developed as therapeutic agents for major depressive disorders and for the treatment of […]

USFDA finds objections on inspecting Alembic Pharma’s Panelav plant

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 the conclusion of an inspection when an investigators observes conditions that in their […]

Cipla dismisses concerns over FDA observations on Goa plant

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 company’s trade with the US, media reports had said. The company’s stock fell […]

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

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 US. Lupin’s product will be called Tydemy. The combination is indicated for use […]

Fortis Healthcare director quits

Fortis Healthcare, which is under the scanner of the Serious Fraud Investigation Office, said one of its independent directors, Joji Gill, stepped down due to ‘personal reasons’. “Ms Joji Sekhon Gill has tendered her resignation from the directorship of the company with effect from March 7 due to personal reasons, primarily attributed to her occupation […]

Maharashtra lifts ban on Jubilant LIfe Sciences’ alcohol production

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 for running a distillery at its factory located at Nira, Maharashtra. He had […]