Alembic Pharma gets USFDA nod for $797 mn generic BP drug

Alembic Pharmaceuticals said it received tentative approval from the US Food & Drug Administration to launch a generic form of blood pressure tablet Opsumit. The tablet, including generic forms such as macitentan, is one of the bigger sellers in the market with estimated annual sales of $797 mn. Most of the generic drugs sold by […]

Sun Pharma to bring molnupiravir COVID-19 pill to India in 1 week

Sun Pharmaceutical Industries said it has received Emergency Use Authorization or EUA from India’s Drugs Controller General of India (DCGI) to manufacture and market a generic molnupiravir in India, a week after the US-FDA gave an EUA to its use in the US. The company has promised to make the oral drug, under the brand […]

Zydus Cadila gets USFDA nod for Acadia’s Parkinson’s drug

Zydus Cadila said it received tentative approval from the USFDA to market Pimavanserin tablets — a generic form of Acadia Pharmaceuticals’ Nuplazid — in the US. Tentative approval refers to approval given ahead of patent expiry. The company will be able to start selling the drug only when the patent protection expires. The compound, as […]

Strides Pharma starts making Sputnik COVID vaccine in India

Strides Pharma Science Ltd said its mega vaccine plant in Bangalore is ready and has started commercially producing Russian COVID vaccine Sputnik Light. “As previously committed, the company is on track to commercialize this vaccine for Global markets in Q4FY22,” it added. Strides Pharma unit Stelis was the third pharma manufacturer in India to sign […]

Advanced Enzyme Tech appoints distributor for South East Asia

Advanced Enzyme Technologies Ltd, India’s largest food supplement enzyme manufacturer, said it has appointed an exclusive distributor for Indonesia, Malaysia, Philippines, Singapore, Thailand & Vietnam. The distribution agreement with Singapore-based Azelis covers all food enzymes and probiotics for the food & dietary supplement industry. Azelis sells chemical and food ingredients in over 50 countries across […]

Biocon expands to Middle East with out-licensing deal

Biocon, one of most prominent Indian pharmaceutical companies focused on developing its own drugs and formulations, kicked off its expansion into the Middle East market with an out-licensing deal with Saudi Arabia-based Tabuk Pharmaceutical Manufacturing Co. Biocon did not list the products that are covered by the licensing deal, but said it would cover “select […]

Morepen Labs’ exports to get ‘major boost’ with FDA nod for Allegra

Morepen Laboratories said it expects its US export business to get a major boost now that the US FDA has given it the go-ahead to export allergy drug Allegra to that market. Fexofinadine, invented by Sanofi Aventis, is the most widely used, second generation antihistamine drug for the treatment of allergy symptoms and hay fever, […]

Survey says allergies may actually protect people from COVID

An interesting, observational study in the UK suggests that the overactive immune system associated with allergic diseases such as asthma and hay fever may have a positive side-effect in the form of greater protection from COVID-19 in the initial stages. The 10-month study, involving around 15,000 people, was carried out between May 2020 and February […]

Zydus Cadila starts crucial trial for fatty liver drug

Cadila Healthcare, also known as Zydus Cadila, said it has started enrolling patients in a trial that can potentially yield the first FDA approved treatment for NASH or non-alcoholic fatty liver disease with inflammation. Fatty liver disease, caused by the deposition of fat in the liver, is divided into alcohol-related and non-alcohol related. Within non-alcoholic […]

Biocon’s insulin glargine approved by US pharmacy benefits manager

Biocon subsidiary Biocon Biologics Limited (BBL) said its insulin substitute Insulin Glargine has been included by Express Scripts — a prominent ‘pharmacy benefits manager’ in the US — in its National Preferred Formulary. Pharmacy benefits manager, as the name implies, is a kind of outsourced service provider that manages pharmacy benefits extended to employees by […]

After EU, Lincoln Pharma gets Australian approval for plant

India-based Lincoln Pharmaceuticals Ltd said it is looking forward to entering the Australian market, after Australia’s medicines and medical devices regulator – Therapeutic Goods Administration {TGA) – approved the company’s primary manufacturing plant in Khatraj, Gujarat. The approval, said the medicine manufacturer, has been granted for all three sections, tablets, capsules and creams & ointments. […]

Max Healthcare wins two plots in HUDA auction, to add 1,000 beds

Max Healthcare Institute Ltd, one of India‚Äôs largest hostpital chains, said it has been allocated around 11.36 acres of land in the heart of Gurgaon city to set up two hospitals. The two plots, allocated by Haryana Shahri Vikas Pradhikaran, measure 6.11 acres and 5.26 acres. Both plots are in well populated areas of Gurgaon, […]

Biocon launches cancer medicine in the US

Biopharmaceuticals manufacturer Biocon Ltd launched cancer medication Everolimus tablets in the US. The formulation, a generic version of Afinitor from Novartis, is a prescription medication that is used to treat certain types of cancers and tumours. The tablet has annual sales of around $675 mln in the US, which makes it among the larger drugs […]

Biocon Malaysia insulin aspart plant hit with 6 observations by US FDA

Six months after getting a VAI status from the US Food & Drug Administration for its insulin glargine manufacturing facility in Malaysia, Biocon — India’s largest biopharmaceuticals company — said the US FDA issued six observations after pre-approval inspections at its insulin aspart plant in that country. Insulin glargine is a long-acting insulin-substitute, while insulin […]

Zydus Cadila signs deal with Shipa Medicare for ZyCoV-D production

Cadila Healthcare, also known as Zydus Cadila, has taken one more step towards augmenting the production capacity for its DNA-based Covid vaccine known as ZyCoV-D by inking an agreement with Shilpa Medicare. Under the agreement, Shilpa Medicare Ltd will use its biologics manufacturing plant at Dharwad, Karnataka, to manufacture ZyCoV-D. ZyCoV-D is the world’s first […]

Zydus Cadila gets US-FDA nod for antidepressant drug

Zydus Cadila said it received approval from the US Food & Drug Administration to sell new generation anti-depressant Vortioxetine in the US market. The drug was first approved around seven years ago, and was developed by Denmark-based pharmaceuticals maker Lundbeck in the late 2000s. Around 2007, Japanese pharmaceuticals maker Takeda agreed to pay an upfront […]

Lupin gets license to manufacture new TB drug

Indian pharmaceuticals manufacturer Lupin Ltd said it received a non-exclusive license to manufacture the anti-TB drug pretomanid from non-profit drug developer, TB Alliance. The company said it plans to sell the drug in 140 countries and territories, including many of the highest TB burden countries around the world. Pretomanid will be administered as part of […]

Zydus Cadila gets 6-month exclusivity in US for arthritis drug

Zydus Cadila said it received six-month exclusivity for the sale of generic tofacitinib, a drug that has annual sales of over $2 billion in the US. The exclusivity was provided by the US FDA, since Cadila Healthcare was the first to file an abbreviated new drug application or ANDA for the drug. An ANDA is […]