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Strides Pharma Facility Receives USFDA Warning Letter 

Strides Pharma has received a warning letter from USFDA for its Puducherry facility. The United States Food and Drug Administration (USFDA) previously had classified the company’s Puducherry facility as Official Action Indicated (OAI). Relating to this, as further development, the company clarified of receiving a warning letter from the USFDA for the same facility. According to the press release, six Abbreviated New Drug Application (ANDA) being produced at the site won’t have an impact but other 10 ANDAs which are pending approval will be deferred till the site gets reclassified. An ANDA contains data which are submitted to the USFDA for review and seek approval of manufacturing a generic drug product. 

Strides Pharma Science Limited is a pharmaceutical company headquartered in Bangalore, India. The company develops, manufactures and markets pharma products for regulated and emerging markets. It has four USFDA approved facilities and two facilities for emerging markets. The company also has an in-house research and development infrastructure in India. 

Rallis India: Pollution Regulator Suspends Operation At Dahej Plant 

Rallis India has received a communication from the Gujarat Pollution Control Board (GPCB) directing the company to suspend its operations at one of its units in Dahej, Gujarat. The suspension came following an incident which took place while dechoking a blocked discharge line of the Agitated Thin Film Dryer (ATFD) unit of the effluent treatment plant. 

The company informed the bourses that there was no environmental and material impact to the plant, but unfortunately, it resulted in a hot liquid bum injury to two workmen. The company said that it is taking necessary steps to restore the said unit's operations at the earliest. Rallis ensured that it does not expect any adverse impact on the business as it is holding adequate stocks of finished goods in its inventory. 

Sadbhav Infrastructure To Monetise Its Assets 

Sadbhav Infrastructure Project Limited (SIPL), subsidiary of Sadbhav Engineering, has entered into a definitive agreement with IndInfravitTrust for sale of the entire shareholding of SIPL in nine operational road projects at an enterprise value of Rs.6,610 crore. Upon completion of the transaction, the company will receive Rs.1,900 cash and 10 per cent of IndInfravit units aggregating to an equity value of Rs.2,550 crore against equity investment of Rs.1,500 crore. The company's Roads Portfolio consists of seven toll roads and two annuity roads, with total 2,619 lane kms in Gujarat, Karnataka, Maharashtra, Rajasthan and Telangana, some of India’s most economically vibrant states. 

The company further informed that the divestment of these nine assets will result in de-consolidation of net debt of Rs. 4,060 crore for Sadbhav Infra. Notably, the assets are valued at a strong Rs.2,550 crore as against equity investment of Rs.1,500 crore. The company will continue to do routine and major maintenance (Rs.4,000 crore contracts for remaining concession period) and will get Project Management fees linked to toll collections for 9 transaction assets. This transaction will help Sadbhav Infrastructure to reduce stress on its balance sheet and free up equity capital to deploy capital for future projects. IndInfravit is sponsored by L&T Infrastructure Development Projects Ltd. 

KPTL To Buy 19.94 Per Cent Stake In Shree Shubham Logistics 



KPTL to acquire 19.94 per cent stake in Shree Shubham Logistics for consideration of Rs.64.66 crore by signing a definitive agreement with Tano India Private Equity Fund II (Tano). 

As per the agreement, the company will pay the consideration via a non-cash equity-swap transaction in which 12,54,900 equity shares of KPTL will be issued to Tano at a value of Rs.515.25 per share subject to approvals. After completion of the acquisitions, KPTL’s stake in Shree Shubham Logistics Limited (SSL) will be 100 per cent. This deal will help KPTL offer quality agricultural warehousing solutions. 

Kalpataru Power Transmission Limited is an EPC company engaged in the business of power transmission & distribution, oil & gas pipeline, railways, infrastructure development, civil contracting and warehousing & logistics business.

Alembic Pharma Bags USFDA Approval For Febuxostat Tablets 



Alembic Pharmaceuticals Limited has received USFDA approval for its Abbreviated New Drug Application (ANDA) Febuxostat Tablets, 40 mg and 80 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD) Uloric Tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals USA, Inc. (Takeda). 

Febuxostat Tablet is a xanthine oxidase (XO) inhibitor indicated for the management of chronic hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Febuxostat Tablet is not recommended for the treatment of asymptomatic hyperuricemia. 

Alembic had previously received tentative approval for this ANDA. Alembic now has a total of 98 ANDA approvals (87 final approvals and 11 tentative approvals) from USFDA. According to IQVIA, Febuxostat Tablets have an estimated market size of US$ 578 million for twelve months ending December 2018.

NCC Strengthens Order Book By Rs358.9 Crore In June 


Hyderabad-based construction company NCC made a stock exchange filing notifying about its fresh order book for the June 2019. The company received two new orders totalling to Rs358.9 crore, excluding GST, in the month of June 2019, said the company in a filing to the exchange. Of these, one order worth Rs163.8 crore is for its Roads Division while the second order worth Rs195.1 crore is for the company's Electrical Division. These orders are from state government agencies and do not include any internal orders. 

The company was recently in news after reports that the Andhra Pradesh government has proposed to cancel some of the contracts which were awarded NCC. The company had clarified that even if this happens, the company only faces a risk of losing around Rs6,100 crore while its order book is worth Rs41,197 crore. This order book will help the company maintain a turnover similar to that of last fiscal in FY20. 

Cyient Denies Developing Flight Test Software For Boeing 

Indian software engineers are being held response for faults in coding software of flight-test equipment for Boeing's 737 Max aircraft. Two Indian IT firms HCL tech and Cyient have partnerships with Boeing. 

US-based publications claimed that HCL Technologies and Cyient were involved in developing flight-display software and flight-test equipment for Boeing. The inaccuracy of these software code are cited as one of reasons for the issues faced by the failure of the Maneuvering Characteristics Augmentation System (MCAS) deployed in 737 Max aircraft. Failure of Boeing's MCAS is linked to two fatal crashes of 737 Max in October 2018 and March 2019. 

However, Boeing has denied that neither HCL Tech nor Cyient were involved in development of MCAS. Similarly, in a statement to the exchanges, Cyient has refuted claims that the company was involved in development of Boeing 737 MAX's software systems. 

Ahluwalia Contracts Wins Contracts Worth Rs262.23 Crore
 

The leading construction company has secured an order inflow of Rs262.23 crore for FY19-20, as of the end of June. The new order wins are for construction of institutional, commercial complexes including electrical, plumbing and firefighting works. 

Ahluwalia Contracts (India) announced that the company has secured new orders aggregating to Rs262.23 crores for building institutional and commercial complexes and scope of work includes electrical, plumbing and firefighting services. Of these, new orders of Rs130 crore are for the construction of Amity University in Mohali, Punjab and worth Rs132.23 crores for other construction work. The company is also expecting a project valued around Rs874 crore in which is has secured L1 status. 

Ahluwalia Contracts is an integrated construction company with expertise in buildings residential and commercial project, hotels, hospital and medical colleges. The company has more than 45 ongoing projects across 23 cities in 9 states. The company focuses on government projects with a continuous reduction of exposure to private sectors. 


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