Page 19 - Pharmaceutical
Ajanta Pharma receives US FDA approval for omeprazole capsules
The company has launched omeprazole and sodium bicarbonate capsule, a generic version of Santarus Inc's Zegerid, in two strengths - 20 mg/1100 mg and 40 mg/1100 mg
 "Ajanta Pharma receives US FDA approval for omeprazole capsules")
SPARC licenses epilepsy drug Elepsia XR to Sun Pharma
The company will receive an up-front payment of $10 million from Sun Pharma, which will market the product (levetiracetam extended release tablets) in the US
 "SPARC licenses epilepsy drug Elepsia XR to Sun Pharma")
Biocon introduces insulin glargine in Japan for diabetes patient
The company, through its partner Fujifilm Pharma, aims to capture a significant share of the Japanese glargine market, estimated by IMS Health at $ 144 million
 "Biocon introduces insulin glargine in Japan for diabetes patient")
Amgen and Daiichi Sankyo to jointly commercialise biosimilars in Japan
The deal includes several products in late-stage development, including biosimilars of adalimumab, bevacizumab and trastuzumab
 "Amgen and Daiichi Sankyo to jointly commercialise biosimilars in Japan")
Vascon Engineers opens clean room partitioning systems plant in Thane
While clean room partitioning systems are mainly used in pharma and healthcare industry, demand is also expected to come from defence, auto component, semi-conductor and solar sectors
 "Vascon Engineers opens clean room partitioning systems plant in Thane")
Indian companies gearing up to solve the biosimilars puzzle
US President is pushing for setting the exclusivity period for biologic drugs at 7 years instead of 12. If this happens, Indian companies should be ready for a windfall of opportunities
 "Indian companies gearing up to solve the biosimilars puzzle")
AMRI completes acquisition of Italian API maker Euticals
The acquisition positions AMRI as one of the largest independent developers and suppliers of active pharmaceutical ingredients (APIs) to the pharmaceutical industry in Europe
 "AMRI completes acquisition of Italian API maker Euticals")
Apax Partners acquires subsidiaries of Spanish pharma firm Invent Farma
This follows Apax Partners' recent acquisition of Neuraxpharm Arzneimittel GmbH, a leading German pharmaceutical company
 "Apax Partners acquires subsidiaries of Spanish pharma firm Invent Farma")
Cipla aims to make biosimilars affordable with new South African plant
The new plant, to be built with an investment of about Rs 600 crore, will be run independently of existing pharma manufacturing division, Cipla Medpro Manufacturing
 "Cipla aims to make biosimilars affordable with new South African plant")
India should reject efforts weakening access to generic drugs
MSF urged Modi to defend India's lifeline to South Africa and developing countries through affordable versions of new medicines
 "India should reject efforts weakening access to generic drugs")
India beats China in pharma exports: Commerce Ministry
According to the Ministry, India's pharma exports grew from $ 11.66 billion to $ 12.54 billion in 2015, while China increased its exports from $ 6.59 billion to $ 6.94 billion
 "India beats China in pharma exports: Commerce Ministry")
Novo Nordisk invests $ 59 mn to expand insulin plant in Denmark
Kalundborg facility produces 50 percent of the world's insulin as well as a range of biopharmaceutical products
 "Novo Nordisk invests $ 59 mn to expand insulin plant in Denmark")
FDC receives US FDA's positive inspection report for Baddi plant
However, the company has received two minor observations from the US drug regulator for its Waluj (Maharashtra) facility
US FDA completes inspection of Strides Shasun's Bangalore facility
The company says the inspection was completed without issuance of Form 483, which is issued by US FDA for violations of good manufacturing practices
 "US FDA completes inspection of Strides Shasun's Bangalore facility")
Sanofi, Boehringer Ingelheim ink animal health-consumer healthcare business swap pact
While Boehringer Ingelheim will transfer its CHC business to Sanofi, in return it will get Sanofi's animal health business Merial. In addition, Boehringer Ingelheim will pay Sanofi Euro 4.7 bn
 "Sanofi, Boehringer Ingelheim ink animal health-consumer healthcare business swap pact")
RPG Life Sciences ties up Italian firm to foray into cosmetics
Through the tie-up with Labo Cosprophar, the Mumbai-based pharmaceutical company will launch two new products for hair and skin care
 "RPG Life Sciences ties up Italian firm to foray into cosmetics")
Impact of Brexit to be majorly on drug and medical device regulation: Report
The European Medicines Agency (EMA), which is headquartered in the UK, is likely to be swiftly relocated to the EU, says GlobalData in a whitepaper
 "Impact of Brexit to be majorly on drug and medical device regulation: Report")
DCGI grants permission for India's first siRNA drug trial
Biocon and the US-based Quark to start phase II/III study of a novel siRNA (small interfering RNA) drug candidate (QPI-1007) in rare eye disease in India
Lupin receives US FDA nod for generic Activella tablet
Tablet is indicated in a woman with a uterus for treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis
Introduce data protection as an IPR: Study
The Assocham-TechSci Research study also suggested for digitisation of IPR for pharmaceuticals in India to strengthen online processing
 "Introduce data protection as an IPR: Study")