Nothing more to disclose on aircraft grounding: IndiGo

Responding to media reports that 12 of its Airbus A320 Neo aircraft have now been grounded, Interglobe Aviation, which operates the IndiGo Airlines, denied that any new development had taken place in this regard that merited public disclosure. “There is nothing material at this stage to comment beyond our earlier letter…” it said, referring to […]

USFDA finds objections on inspecting Alembic Pharma’s Panelav plant

Alembic Pharmaceuticals said it has been issued with a Form 483 by the US Food and Drug Administration after the drug regulator conducted a routine inspection of its formulations facility in Panelav in Gujarat. Form 483 is issued to firm management at the conclusion of an inspection when an investigators observes conditions that in their […]

Cipla dismisses concerns over FDA observations on Goa plant

Pharma major Cipla dismissed concerns about adverse observations by the US Food and Drug Administration on one of its manufacturing plants in Goa. The Goa plant is one of the company’s largest manufacturing locations for exports, and the observations could affect the company’s trade with the US, media reports had said. The company’s stock fell […]

Edelweiss abandons acquisition of Religare’s securities business

Edelweiss Financial Services Ltd said it abandoned the deal to acquire the securities business of Religare Enterprises, including the company’s securities and commodities broking and depository participant services. “Due to the seller’s inability to obtain the requisite clearances within the agreed timeline, the binding agreement has come to an end on March 15, 2018,” Edelweiss […]

Indigo, Go Air can use grounded planes after changing engines: Jayant Sinha

Aviation minister Jayant Sinha said India’s largest airline Indigo and competitor Go Air can use their grounded planes if they are able to secure ‘alternative engines’ to be used in place of the faulty ones. “We do not consider these engines safe,” Sinha said in the context of the aviation sector regulator’s directive to ground […]

Star India threatens Airtel Digital with complete disconnection of channels

Taking the fight up a notch, Star India, the biggest television broadcaster in the country, has threatened to disconnect all its 56 channels currently aired by Airtel Digital, India’s second-biggest DTH network. “Dear Airtel Digital customer, your favorite channel.. along with all 56 channels in Star India bouquet is likely to be disconnected on Airtel […]

Fortis Healthcare director quits

Fortis Healthcare, which is under the scanner of the Serious Fraud Investigation Office, said one of its independent directors, Joji Gill, stepped down due to ‘personal reasons’. “Ms Joji Sekhon Gill has tendered her resignation from the directorship of the company with effect from March 7 due to personal reasons, primarily attributed to her occupation […]

Jet Airways to challenge CCI penalty in price fixing case

Jet Airways said it will challenge the order of the Competition Commission of India to impose a fine of Rs 39.81 cr  for allegedly colluding with its rivals to fix air fares. In a statement on Wednesday, the Competition Commission said Jet Airways, SpiceJet and IndiGo engaged in “concerted action in fixing and revising Fuel […]

Maharashtra lifts ban on Jubilant LIfe Sciences’ alcohol production

Pharma company Jubilant Life Sciences said the government of Maharashtra has stayed the order passed by state excise commissioner stopping the production of alcohol at one of its plants in the state. On March 3, the commissioner had canceled the company’s licenses for running a distillery at its factory located at Nira, Maharashtra. He had […]

Dr Reddy’s says EU approves production at Duvvada plant in Andhra

Pharma major Dr Reddy’s Laboratories said European Union authorities have again allowed it to produce drugs for sale in the EU region at its Duvvada factory in Andhra Pradesh. In its inspection conducted in September, the Regulatory Authority of Germany (Regierun von Oberbayern) had made six major observations on the formulations manufacturing facility near Vishakapattanam. […]

Lupin gets USFDA warning on Goa, Indore plans, to affect new approvals

Pharma major Lupin said it a warning letter from the US Food and Drug Administration for its formulations manufacturing facilities in Goa and Indore on Monday. “We are deeply disappointed to hove received this outcome. While there will be no disruption of existing product supplies from either of these locations, there will likely be a […]

Dr Reddy’s hit by class action suit on “misleading statements” on FDA action

Pharma giant Dr Reddy’s Labs today said that a class action lawsuit has been filed against it on behalf of shareholders, alleging that the company misled investors causing them to lose money on their investments. “The lawsuit alleges that the company made materially false and/or misleading statements or omissions in connection with its corporate quality […]

Unichem Labs Ghaziabad plant inspected by USFDA

Generic drug manufacturer Unichem Laboratories said its formulations manufacturing facility at Ghaziabad has successfully exited an inspection by the US Food and Drug Administration. It received an Establishment Inspection Report (EIR) from the USFDA, the company said. “This receipt indicates the successful closure of the inspection and the queries raised during the audit (Form 483). […]

Zydus Cadila gets USFDA approval for generic form of colitis drug Lialda

Zydus Cadila said the US Food and Drug Administration has given the final approval to market the company’s Mesalamine Delayed-Release Tablets in the US market. Zydus Cadila was the first to file an Abbreviated New Drug Application (ANDA) for a generic version of Lialda. Lialda is indicated for the treatment of mild to moderate ulcerative […]

Sharon Bio Medicines receives FDA approval for Tajola API plant

Indian Pharmaceutical company Sharon bio medicine Ltd said it received the Establishment Inspection Report (EIR) from United States Food and Drug Amnistration for its manufacturing plant located at Tajola in Raigad Dist., Maharashtra. The plant, which will make Active Pharmaceutical Ingredients is now approved by the USFDA and the generic drug user fee is pending. […]