Top Headlines Of The Day:- 30 Jan 2018
Jubilant receives ANDA approval for Clonidine Hydrochloride ER Tablets
KPIT and Birlasoft to come together to create two entities
Mylan and Biocon receive positive CHMP opinion for Insulin Glargine
Amber Enterprises lists at 38% premium to issue price
HCL Tech gets 5-year order from Cadent for IT Infra services
Jubilant receives ANDA approval for Clonidine Hydrochloride ER Tablets
Jubilant Life Sciences has announced that its material wholly owned subsidiary Jubilant Pharma Limited has received Abbreviated New Drug Application (ANDA) final approval for Clonidine Hydrochloride Extended-Release Tablets, 0.1 mg. This is a generic version of Kapvay of Concordia. It is used for the treatment of attention deficit hyperactivity disorder (ADHD).
As on December 31, 2017, Jubilant had a total of 86 ANDAs for Oral Solids filed in the US of which 56 had been approved and 12 Injectable filings of which 10 had been approved. This is the eighth USFDA approval in FY18.
Clonidine Hydrochloride Extended-Release Tablets, 0.1 mg had annual sales of ~USD 66 million in the US as per IMS MAT Jun 2017.
KPIT and Birlasoft to come together to create two entities
KPIT Technologies had informed the exchanges that its board had approved a draft composite scheme for amalgamation of Birlasoft (India) with KPIT. The second leg of the transaction would involve demerger of the engineering business of the company into KPIT Engineering Limited (KEL), a wholly owned subsidiary of the company and will be renamed as KPIT Technologies Limited.
According to the arrangement, shareholders of Birlasoft will receive 22 equity shares of the combined KPIT -Birlasoft for every nine equity shares of Birlasoft. the combined KPIT-Birlasoft will be engaged in the ITSS Business, and pursuant to the Proposed Demerger, KEL's shares will be listed and shareholders of combined KPIT-Birlasoft will receive one share of KEL for each share they hold in the combined KPIT-Birlasoft.
Mylan and Biocon receive positive CHMP opinion for Insulin Glargine
Biocon has announced that it, along with its partner Mylan, has received a positive opinion from Europen Medical Agency’s (EMA) - Committee for Medicinal Products for Human Use (CHMP) - for insulin Glargine. CHMP has also recommended approval to Insulin Glargine, which will be sold under brand Semglee.
There are ~60m people affected by diabetes in Europe with an increasing prevalence in the region. Insulin Glargine is a biosimilar, which will be available for commercialization once it receives EMA approval.
Biocon and Mylan are also awaiting approval for Insulin Glargine in Australia, Canada, and the US and are planned for key Emerging Markets.
Amber Enterprises lists at 38% premium to issue price
Amber Enterprises listed at a significant premium of 38% to its issue price of Rs855-859 and is currently trading at Rs1, 187.2.
The IPO offer consisted of Fresh Issue of 55.3 lakh shares (aggregating up to ~Rs475cr) at the upper end of the price band. It also includes an offer for sale of up to 14.6 lakh shares (Rs125cr) by the promoters. The issue proceeds will be used for pre-payment or repayment of borrowings (~Rs400cr) and for other general corporate purposes (~Rs75cr).
HCL Tech gets 5-year order from Cadent for IT Infra services
HCL Technologies (HCL) announced a five-year IT infrastructure services and application management contract with Cadent, the UK’s largest gas distribution network. The ground-breaking ‘cloud first’ multi-service deal will see HCL provide integrated public cloud hosting and SAP and Application Maintenance Services, including the migration of a significant applications portfolio to Amazon Web Services (AWS) public cloud. In addition, HCL will provide IT Service Management, Service Desk and Managed Workplace Services.
HCL will deliver these services to support Cadent’s business operations which distributes gas to 11 million homes and businesses in the North West, Midlands, East and South East of England. HCL will provide MWS support to approximately 4,500 staff; including 3,500 field based-engineers who work across the company’s 65 regional depots.
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