Lupin receives EIR for Pharmacovigilance Inspection from USFDA

Pharmaceutical major Lupin said that the United States Food and Drug Administration (USFDA) has given it an Establishment Inspection Report (EIR) for its Mumbai-based global  pharmacovigilance group, Drug Safety & Risk Management (DSRM). Pharmacovigilance, also known as drug safety, is the science relating to the collection, detection, assessment, monitoring and prevention of adverse effects with […]

Glenmark Pharmaceuticals gets USFDA nod for sales of stomach relief capsules

Mumbai-based pharmaceutical firm Glenmark Pharmaceuticals said it received final approval from the United States Food and Drug Administration (USFDA) for sales of a generic equivalent of AstraZeneca Pharmaceuticals’ Nexium-Delayed Release capsules. Esomeprazole magnesium capsules are used to treat certain stomach and esophagus problems such as acid reflux and ulcers. It relieves symptoms such as heartburn, […]

Caplin Point Labs Puducherry unit gets approval from Colombia drug regulator

Indian pharmaceutical manufacturer Caplin Point Laboratories said it received approval from Colombia’s drug regulatory body, The Colombia National Food and Drug Surveillance Institute (INVIMA), for its small volume sterile injectable division at Puducherry. The inspection was carried out on May 10. The Puducherry unit of Caplin Laboratories manufactures liquid injectables in vials, ampoules, lyophilized vials […]

Zydus Cadila gets USFDA approval for sales of hypertension drug

Pharmaceutical manufacturer Zydus Cadila said it received the final approval for sales of a generic equivalent of Pfizer’s Thalitone tablets. Chlorthalidone tablets are used for the treatment of high blood pressure or hypertension. It is also used to treat fluid retention or edema in people with congestive heart failure, cirrhosis of the liver or kidney […]

Hindustan Media Ventures invests in content aggregator Aleph Digital

Hindustan Media Ventures, the Hindi arm of mass media company HT Media Ltd, said it invested Rs 4 crore in the media and entertainment firm Aleph Digital Solutions Pvt Ltd. Incorporated in November 2017, Aleph operates Pebble, a hyper-local content marketplace and LocalHeading, a news site. Pebble offers verified hyper-local content to publishers at an […]

Lupin launches generic epilepsy tablets in the US

Pharmaceutical major Lupin announced the launch of a generic equivalent of Lundbeck Pharms’ Onfi tablets in the US market. Clobazam is used to control seizures in adults and children 2 years of age and older who have Lennox-Gastaut syndrome. Lennox-Gastaut syndrome (LGS) or childhood epileptic encephalopathy is a pediatric epilepsy syndrome characterized by multiple seizure […]

JSPL wins Rs 665 cr rail order from Rail Vikas Nigam

Steel and energy company Jindal Steel and Power Ltd (JSPL) said it received an order worth Rs 665 crore from Rail Vikas Nigam Limited (RVNL) for the supply of over 89,000 tonnes of rails. Rail Vikas Nigam Limited is an organisation associated with the Indian Railways, and builds engineering works for the Indian Railways. JSPL […]

Lupin to sell Aptissen’s products in Canada

Pharmaceutical major Lupin said it signed a distribution agreement with Switzerland-based pharma firm Aptissen S.A. to exclusively sell Aptissen’s products in Canada. Established in 2013, Aptissen develops hyaluronic acid polymer-based injectable medicinal products in aesthetic medicine, ophthalmology, and orthopedics. It has presence in more than 50 countries worldwide. “This partnership helps us expand our product […]

Indoco Remedies’ Baddi facility receives UK MHRA approval

Pharmaceutical company Indoco Remedies Ltd said that its solid dosages facility at Baddi, Himachal Pradesh received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) after a regulatory inspection. The inspection was carried out from October 16-18, 2018, Indoco said. Spread over an area of 18,000 square metre, Indoco’s solid dosages facility at […]

Ratnamani Metals and Tubes receives order worth Rs 255 crore from oil and gas sector

Steel tubes and pipes manufacturing firm Ratnamani Metals and Tubes Ltd said it received a Rs 255 crore order from the oil and gas sector for the supply of coated carbon steel pipes. Carbon steel, also called mild steel, are used in oil and gas pipeline, plumbing and water supply systems. The order will be […]

YES Bank acquires stake in Electrical Engineering firm CG Power and Industrial Solutions

YES Bank, India’s fourth largest private sector bank, said it has acquired 12.79% stakes in Electrical Engineering firm CG Power and Industrial Solutions as part of the invocation of a pledge. It acquired over 8 crore of equity shares of CG Power submitted as collateral for a loan. The shares are valued at Rs 288 […]

Unichem Laboratories receives tentative USFDA nod for sales of allergy drug

Pharmaceutical company Unichem Laboratories said it received a tentative approval from the United States Food and Drug Administration (USFDA) to sell a generic equivalent of Johnson and Johnson Consumer Inc’s Zyrtec-D 12-hour Extended tablets. A tentative approval means that the company has to wait for all patent and other protections to expire before starting the […]

Alembic JV Gets Approval From USFDA For Dermatology Plant in Gujarat

Alembic Pharmaceuticals said one of its dermatology-focused joint ventures, Aleor Dermaceuticals Ltd, received an Inspection Report for its formulation facility at Karakhadi, Gujarat from the United States Food and Drug Administration. The USFDA had conducted an inspection at the facility from February 4-8. Alembic holds 60% of Aleor, with Orbicular Pharmaceutical Technologies holding the rest. […]

Dr Reddy’s Laboratories launches Testosterone Gel in the US

Hyderabad-headquartered Dr Reddy’s Laboratories said it has launched a therapeutic equivalent of AbbVie Inc’s AndroGel in the US market, a month after rival Lupin did so. Testosterone Gel is used for hormone replacement in men who are not able to produce enough testosterone. The medication is absorbed through the skin, enters the bloodstream, and helps […]

Ducon Infratech wins pollution controller order from Exide unit

Information technology firm Ducon Infratechnologies Ltd said it received an order to supply a pollution control system at the greenfield lead metal recycling and refining project of Chloride Metals Ltd, a wholly-owned subsidiary of Exide Industries Ltd and one of India’s largest secondary lead smelter and production company, at Haldia in West Bengal. The pollution […]

Zydus’ Ahmedabad plant gets 14 observations in USFDA inspection

Pharmaceutical manufacturer Zydus Cadila said that the United States Food and Drug Administration has issued 14 observations after an inspection at its manufacturing facility at Moraiya, Ahmedabad. Observations indicate that the inspectors did not find everything up to order, and want the company to make amendments to its procedures and process at the facility. Moraiya […]

Thomas Cook to offer special Sentosa packs to Singapore, signs deal

Travel services company Thomas Cook said it  will offer special deals to customers to Sentosa, an island resort in Singapore, following the signing of a three-year strategic agreement with Sentosa Development Corporation Sentosa Development Corporation (SDC) is a statutory board in Singapore, under the purview of the Ministry of Trade and Industry. Established in 1972, […]

Cipla launches generic Sensipar amid legal battle with Amgen

Pharmaceutical major Cipla and its subsidiary Cipla USA announced the phased launch of a generic therapeutic equivalent version of Sensipar, a branded drug manufactured by Amgen Inc. The launch, however, is a subject of ongoing litigation, Cipla said in a regulatory filing. Amgen’s Sensipar generated US sales of $1.43 billion in 2018. Cinacalcet hydrochloride tablets […]