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.
"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.
"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.
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.
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 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.
"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.
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.
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.
"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.
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.
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.