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What ails India's pharmaceutical sector?

Unlike mature markets such as the US, where drug prices are market-controlled, here, the government and regulators play a pivotal role in the entire process. Regulators fix both the price companies pay for bulk drugs and the price at which they sell their products in the market, leaving little leeway to earn profit. For Indian pharma, this is a double-edged sword.

Wockhardt gets DGCI approval for 2 new antibiotics

"DCGI (Drug Controller General of India) has approved Wockhardt's two new antibiotics, EMROK (IV) and EMROK 0 (Oral), for acute bacterial skin and skin structure infections including diabetic foot infections and concurrent bacteraemia...," the drug firm said. The new drug will target superbug like Methicillin resistant Staphylococcus aureus.

Strides gets USFDA nod for anti-allergic drug

The company said, it is focusing on building a private label business in the US by leveraging its portfolio of products across softgels, tablets, capsules and other proprietary formats.

Alembic gets USFDA nod for Tizanidine hydrochloride capsules used to treat spasticity

"The company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg," the drug firm said in a regulatory filing.

Sun Pharma, US-based Rockwell Medical enter into licensing pact for Triferic in India

As per the terms of the agreement, Sun Pharma will be the exclusive development and commercialisation partner for Triferic during the term of the agreement, subject to its approval in India.

PE Funds Advent, Kedaara in discussions to acquire Sequent

The founder promoters of Sequent, including serial entrepreneur Arun Kumar, KR Ravishankar and family, together hold about 56.5% in the listed entity, while PE investor Ascent Capital holds 5% stake. JP Morgan is running the sale process.

Pharma cos may face Rs 10-lakh penalty, 2-year jail term for deceptive drug ads

Pharmaceutical companies or anybody involved in exaggerating how well their drugs work will face exemplary penalty and imprisonment, according to the proposed amendments to the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.

Granules India says 'voluntarily' recalling ranitidine tabs

Granules India has said that it has received multiple queries on the news item for recall of ranitidine by the drug firm. The company is in the process of recall from channel partners and the exact quantities are being estimated.

Alembic gets USFDA nod for Vilazodone Hydrochloride tablets used to treat depression

"The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Viibryd tablets, 10 mg, 20 mg, and 40 mg, of Allergan Sales," the drug firm said. Citing IQVIA, the company said Hydrochloride tablets, 10 mg, 20 mg, and 40 mg, have an estimated market size of USD 469 million for 12 months ending September 2019.

USFDA classifies inspection of Lupin's Tarapur facility as 'Official Action Indicated'

According to FDA's definitions, Official Action Indicated means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during inspections. The company, however, said that it does not believe this inspection classification will have an impact on disruption of supplies or the existing revenues from operations of this facility.

HC Bars Cipla, 3 others from launching generic version of Bristol-Myers’ drug

HC Bars Cipla, 3 others from launching generic version of Bristol-Myers’ drug

Delhi High Court has granted an injunction restraining the domestic pharma companies such as Cipla, Torrent, Emcure, Alkem from selling a medicine used for prevention and treatment of thromboembolic diseases, the patent for which is held by Bristol-Myers Squibb (BMS) as it filed its claims for patent infringement of Apixaban in Delhi HC.

Solara Active Pharma to conduct internal probe on Nizatidine API amid Mylan recall

Solara Active Pharma to conduct internal probe on Nizatidine API amid Mylan recall

"We understand from Mylan NV's press release dated January 8, 2020, that Mylan Pharmaceuticals has initiated a voluntary recall of three lots of Nizatidine Capsules, USP (150 mg and 300 mg strengths) due to detected trace amounts of impurity...," Solara Active Pharma Sciences in a filing to BSE.

Revised NLEM to classify antibiotics by usage

Revised NLEM to classify antibiotics by usage

New advice differentiating common antibiotics from those to be used for most serious medical conditions is likely in the revised National List of Essential Medicines.

Sun Pharma eyes China, Japan markets

Sun Pharma eyes China, Japan markets

Shanghai now plans to steer the company into the specialty business (novel, innovative drugs), and towards expanding markets like China and Japan for growth, both through acquisitions and partnerships.

Top cancer drugs may come under price control

Top cancer drugs may come under price control

Taking cue from the WHO’s revised list of essential medicines, popular biosimilars for cancer cure may get incorporated in India’s revised National List of Essential Medicines.

Biocon elevates M B Chinappa as CFO of biosimilar subsidiary

Biocon elevates M B Chinappa as CFO of biosimilar subsidiary

M B Chinappa, who is going to play an important role in Biocon Biologics’ journey towards becoming a global leader in biologics, has been tasked to drive financial performance of the company and improve profitability and manage anticipated risks in the journey of achieving the $1 billion revenue target in FY22, said the company in a press release.

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