Alkem’s Taloja test facility passes US FDA inspection

Pharmaceuticals manufacturer Alkem Laboratories said its bioequivalence center at Taloja in Maharashtra has successfully undergone a US FDA inspection without attracting any adverse remarks. “US FDA had conducted a remote and virtual Bio-Analytical inspection of the Company’s Bioequivalence Center located at Taloja, Maharashtra from 26th July, 2021 to 28th July, 2021. At the end of […]

Adani says FPI accounts not frozen

Adani Transmission, a part of the diversified Adani Group, disputed a report by financial newspaper Economic Times that said that NDSL had frozen the share accounts of three foreign investors who held nearly Rs 43,500 cr worth of stock in various Adani group companies. Economic Times had carried the news quoting an update published by […]

Lupin gets US FDA warning letter for Somerset plant

Lupin Ltd, one of the world’s largest generic drug makers, today said it received a warning letter from the US Food and Drug Administration relating to its US-based manufacturing plant located in Somerset, New Jersey. “We wish to inform you that the Company has received a warning letter from the US FDA for the company’s […]

Airtel Digital partially implements TRAI Tariff Order

Airtel Digital, one of the top television channel distributors in India, has partially complied with TRAI’s tariff order as amended on January 1 this year. The company has complied with some provisions of the rules, such as reducing the network charge for up to 200 channels, while compliance with other parts of the tariff order […]

Cable/DTH operators ignore TRAI’s new tariff order

Most cable and DTH operators in India have failed to comply with TRAI’s tariff order issued that came into effect today in perhaps the first such incident in the industry’s history. As of today, the amended provisions of the Telecom Services Tariff Order, notified two months ago, have come into place. However, as of 8 […]

Javadekar supports changes to TRAI tariff order

The recent changes made to the TV channel pricing rules of India by the Telecom Regulatory Authority of India to the tariff order on January 1 are targeted at dealing with the problems faced by the consumer and balancing the interests of various industry participants, Minister of Information and Broadcasting Prakash Javadekar said today. The […]

Biocon gets Form 483 observations for API plant

The US Food and Drug Administration has issued a Form 483 with five observations for Biocon’s API Manufacturing facility. Form 483 observations are issued when US FDA inspectors notice shortcomings in a company’s manufacturing processes, data storage and so on during an inspection. The company has to address the issues raised in the Form 483 […]

TRAI TARIFF ORDER: Jaya TV becomes the first to publish prices

Mavis Satcom, which operates channels under the Jaya TV banner, has become the first broadcasting company to comply with regulator TRAI’s order to publish updated channel prices by end of day today. The company published prices of four channels and one bouquet. The channel prices remain unchanged and range from Rs 0.50 for Jaya Plus […]

No stay on TRAI’s Tariff Order from Bombay HC, yet

The Bombay High Court did not issue a stay on the implementation of the amended TV channel tariff order issued by TRAI on News Year’s day, but kept the possibility open when it takes up the case again on January 22. Broadcasters, under the aegis of Indian Broadcasting Foundation, had approached the Bombay High Court […]

Broadcasters challenge TRAI’s amended tariff order

With just two days remaining for a deadline to file amended TV channel tariffs, a case filed by India’s big broadcasters in the Bombay High Court has been listed for hearing tomorrow in front of Justice SC Dharmadhikari. Broadcasters, including Star India, Zee Entertainment, Sony Networks and others, have come together under the banner of […]

Cadila Healthcare gets US FDA warning letter for Moraiya facility

Cadila Healthcare, one of India’s biggest pharmaceutical companies, said it has received a ‘warning letter’ from the US Food and Drug Administration relating to its Moraiya formulations facility in Gujarat. The Moraiya facility is the company’s largest plant that makes tablets and injectables and is estimated to contribute about 40-50% of its U.S. exports. Shares […]

TV channels get price-cuts ahead of new pricing formula by TRAI

Some of the popular television channels owned by major broadcasters like Star India, Zee Entertainment and TV18 have seen their prices reduced on a temporary basis as the broadcasting regulator puts the final touches on a new law aimed at bringing down individual channel prices and curbing anti-competitive practices. The cuts come barely a week […]

Tata Sky slashes monthly charge under TRAI tariff scheme

Tata Sky, a premium satellite TV provider in India, has unveiled a scheme by which heavy customers can bring down their monthly network fee by up to Rs 300. However, to get the lower network charge — also known as network capacity fee or NCF — a subscriber must buy some television channels picked by […]

Cadila Healthcare Moraiya plant could face FDA action

Cadila Healthcare today said that the US FDA has classified its Moraiya factory near Ahmedabad as ‘official action indicated’ or OAI. OAI is one of the three types of classification that a plant inspection report is put under after an FDA inspection. The three classifications are ‘no action indicated’, ‘voluntary action indicated’ and ‘official action […]

Lupin’s Aurangabad plant passes USFDA inspection

Pharma manufacturer Lupin said its Aurangabad factory has successfully obtained an Establishment Inspection Report (EIR) from the US FDA for its May inspection. The receipt of an EIR signifies the successful closing of the inspection as far as the company is concerned. Lupin’s Aurangabad facility is involved in the manufacture of Oral Solid Dosage, Oral […]

Caplin Point Labs gets 2 observations from US FDA for Chennai plant

Pharmaceuticals maker Caplin Point Laboratories said the US FDA has completed inspection of its Sterile Injectable manufacturing facility at Gummidipoondi in Chennai and issued two observations. The good manufacturing process inspection was done between June 6th and 14th. “The Company believes these to be of procedural in nature and the corrective and preventive actions for […]

Way2Wealth: SAT stays SEBI order in NSE leased line case

The Securities Appellate Tribunal has stayed an order by the stock markets regulator imposing strict restrictions on stock broker Way2Wealth in the ‘NSE leased line’ case. The Securities and Exchange Board of India had, two weeks ago, imposed penalties and restrictions on several parties, including the National Stock Exchange, for facilitating or indulging in unfair […]

Boeing 737 MAX: Spicejet suspends 14 flights, offers refunds

India’s most aggressive low-cost carrier, Spicejet, said it has cancelled 14 flights today due to the grounding of multiple Boeing 737 MAX aircraft. The grounding is the result of a regulatory directive, which was prompted by an accident with an Ethiopian Airlines plane last week, the second Boeing 737 MAX to fall out of the […]

TRAI TARIFF ORDER: Calcutta High Court lifts stay, gives breather to LCOs

The Calcutta High Court has vacated the stay it imposed on the implementation of the new tariff scheme by TRAI, even as it gave extra time for cable operators to negotiate a deal with their feed suppliers. The stay was imposed two days ago after cable operators said that the new rules would hurt them […]