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Zydus Cadila Gets USFDA Approval For Colesevelam Hydrochloride Tablets 

Zydus Cadila has received the final approval from the United States Federation of Drug Authority (USFDA) to market Colesevelam Hydrochloride Tablets, (US RLD - Welchol), 625 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is used along with a proper diet and exercise, to lower cholesterol in people with high levels of cholesterol in the blood. Lowering cholesterol decreases the risk of heart disease and helps preventing strokes and heart attacks. 

The group now has 273 approvals and has so far filed over 360 ANDAs since the commencement of the filing process in FY 2003-04. Last month, the company had also received the USFDA approval A to market Clobetasol Propionate Lotion, (US RLD - Clobex Lotion), 0.05%. It will be manufactured at the group's topical manufacturing facility at Ahmedabad. This medication is used to treat a variety of skin conditions like eczema, psoriasis, dermatitis, allergies and rash. Clobctasol reduces the swelling, itching and redness that can occur in these types of conditions. 

BHEL bags new orders 

BHEL announced that it has won orders for the Turbine Generator and associated packages for the greenfield 2x660 MW Khurja Super Thermal Power Project situated at Bulandshahr district of Uttar Pradesh.The said order amounts to `1600 crore and the order was placed by THDC India, which is Joint Venture between Govt. of India and the Govt. of Uttar Pradesh. BHEL has been a key partner in the power development programme of Uttar Pradesh. Considerably, BHEL has contributed nearly 74 per cent of UP’s coal-based power generation capacity, totaling to around 17,000 MW. BHEL is India’s leading engineering and manufacturing company of its kind. It is a power plant equipment manufacturer and operates as an engineering and manufacturing company. 

TCS Forms Strategic Partnership With L&G 

Tata Consultancy Services Limited has announced that it has expanded its strategic partnership with Legal & General (L&G) to help L&G transform into a digital workspace, leveraging TCS' Machine First Delivery Model and design thinking approach. 

L&G is one of the UK's leading financial services groups and a major global investor. It began its relationship with TCS in 2008. As a strategic partner, TCS has delivered many successful programs across various lines of business, including an agile transformation, SmartQuote services for general insurance, Solvency ll, and Retail Distribution Review implementation. 

The expanded partnership with TCS will help L&G build an intelligent and automated digital workspace aligned to its business vision. Additionally, a highly personalized, next-gen service desk will provide real-time analytics for location-aware services and enterprise-wide social collaboration. 

TCS' comprehensive Digital Workspace services and solutions, enabled by user empathetic design and agile execution, help enterprises create intuitive, immersive and intelligent workspaces. These services include an in-house platform designed to host a complete suite of digital workspace components that create delightful employee experiences with persona-based delivery, predictive healing, advanced analytics, cognitive IT support, chatbot assistance, knowledge as a service, modern device management, and more. Legal & General, established in 1836, is one of the UK's leading financial services groups and a major global investor, with international businesses in the US, Europe, Middle East and Asia. 

Raymond To Sell Its Thane Property 

J K Investo Trade (India) (JKIT), associate company of Raymond has entered into an Agreement For Sale (AFS) for its property located at Thane. The AFS is with Elpis Ventures, an affiliate of Virtuous Retail South Asia Pte for the property comprising of approximately 78,310 sq. mtrs. According to AFS, JKIT has agreed to sell the aforesaid property for a consideration of Rs. 700 crore subject to payment of taxes, cost of approvals, as applicable and terms & conditions set out in the AFS. 

Raymond has forayed into real estate business in FY19. Around 20 acres of land has been approved for residential development and, at present, 14 acres are being developed. In this residential project, Raymond will develop overall 3,000 residential units across 10 towers. The company has received strong response for these apartments with around 450 applications through soft launch. The project is likely to be completed in five years and the company would not go for external funding as a large portion will be funded by the revenue accretion from this segment. 

Raymond is a diversified group with presence in textiles and apparels, FMCG, auto components, engineering and real estate sector. The company’s revenue mix as of FY19 stood as follows: textiles (44.2 per cent), shirtings (8 per cent), apparels (26 per cent), garmenting (11.2 per cent), tools & hardware (5.4 per cent), auto components (3.6 per cent) and others (1.3 per cent). 

Glenmark’s Baddi Facilty Receives Warning Letter From USFDA 

Glenmark Pharmaceuticals has informed that US FDA has issued a warning letter for its Baddi facility at Himachal Pradesh. The said facility was inspected by US FDA during 15th to 20th April of 2019. At that time it was classified as ‘Official Action Indicated’ implying regulatory/administrative actions will be recommended. Now, US FDA has issued this warning letter for the same facility. 

The company in its exchange filing said that it is in the process of preparing a detailed response to the USFDA within 15 working days. It has also clarified that this warning letter would not disrupt its existing manufacturing and sales of products from Baddi plant. 

Glenmark has generated nearly 7 per cent of its US sales (USD 30 million) from this facility. Furthermore, in the next one year there are no major pending approvals from this facility. Besides, in the recent quarter (Q1FY20), the company has generated nearly 31.5 per cent of its consolidated sales from US. 

At present the company has eight US FDA approved manufacturing facilities of which five are formulations facilities and three are API facilities under Glenmark Life Sciences Limited. As of now, Glenmark has been reported with issues only for Baddi facility. 

Indoco Remedies Gets USFDA Approval For Its Rasagiline ANDA 

Indoco Remedies Limited has received the final approval for its Abbreviated New Drug Application (ANDA) for Rasagiline 0.5 mg and 1 mg tablets from the United States Food & Drug Administration (USFDA). 

Rasagiline is used for treatment of Parkinson's disease. The market size of this product in the US as per IMS 2018 data is USD 105 million. 

As per the management of the company, this is the first ANDA approval for Indoco after receipt of warning letter in March 2017 for Goa plant II and III. The Company has 32 ANDAs pending for approval for different dosage forms from this site. 

Indoco Remedies is a research-oriented pharma Company with presence in 55 countries. It has 9 manufacturing facilities, 6 of which are for FDFs and 3 for APls, supported by a state-of-the-art R&D Centre and a CRO facility.


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