The latest news from the Indian pharma industry, including Dr. Reddy’s purchase of Mayne Pharma’s US portfolio; Sun Pharma’s acquisition of Concert Pharma; Bristol Myers Squibb’s expanded Indian footprint and the Cipla manufacturing site under FDA scrutiny.
Dr. Reddy’s to buy Mayne Pharma’s US business for USD 105 million (Fortune India)
Dr. Reddy’s entered into a definitive agreement for the US generic prescription product portfolio of Salisbury, Australia-based Mayne Pharma Group Ltd. The portfolio includes 45 commercial products, four pipeline products and 40 approved non-marketed products, including many generic products, focused on women’s health, the company informed via a stock exchange filing. For the financial period ending June 30, 2022, Mayne Pharma reported total revenue of $111 million (USD) for the acquired portfolio.
Sun Pharma Completes Acquisition of Concert Pharmaceuticals (Indian Pharmapost)
Sun Pharmaceutical has announced the successful completion of its acquisition of Concert Pharmaceuticals, a late-stage clinical biopharmaceutical company that is developing deuruxolitinib, a novel, deuterated, oral JAK1/2 inhibitor, for the potential treatment of adult patients with moderate to severe alopecia areata.
“We are excited to add deuruxolitinib, a late-stage, potential best-in-class treatment for alopecia areata, to our growing global dermatology portfolio and expand our presence in the Boston biotech hub,” said Abhay Gandhi, CEO – North America, Sun Pharma.
Alembic Pharmaceuticals USFDA Final Approval for Fluorouracil Injection (Indian Pharmapost)
Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Pharmacy Bulk Vial.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Fluorouracil Injection, 2.5 g/50 mL (50 mg/mL), of Spectrum Pharmaceuticals, Inc. (Spectrum).Fluorouracil Injection is indicated for the treatment of patients with adenocarcinoma of colon and rectum, adenocarcinoma of the breast, gastric adenocarcinoma and pancreatic adenocarcinoma.
India Cracks Down on Pharma Firm Marion Linked to Uzbekistan Deaths (Reuters)
Indian police on Friday arrested three employees of a pharmaceutical firm whose cough syrups were linked to the deaths of 19 children in Uzbekistan, a police officer said, as the country looks to recover from recent setbacks to the industry.
The arrests were made after tests by an Indian government laboratory found 22 drug samples of Marion Biotech Pvt Ltd, based near New Delhi, “adulterated and spurious,” according to a police document seen by Reuters.
India Emerges as US’s New Destination for “Friend-shoring” Pharmaceutical Supply Chains (Business Insider India)
China’s Covid-related lockdowns in 2022 crippled the flow of important pharmaceutical products around the world. The events are prompting a reconsideration of the structure of international supply networks, along with geopolitical competitiveness and macroeconomic pressures. India may become a destination in the US’s new “friend-shoring” policy for the pharmaceutical industry, reported Hinrich Foundation. The term friend-shoring is used for the act of moving supply networks to nations with little chance of political unrest disrupting them.
Bristol Myers Expands Footprint in India with Drug Development and IT Centre (Endpoints)
Pharma giant Bristol Myers Squibb will expand its footprint in Hyderabad, India, with a life sciences hub that will focus on IT and drug development. It’s expected to be operational by the middle of 2023. The company will invest about $100 million into the center and will employ around 1,500 people, according to local news sites. The exact location of the center in the region is unknown.
Thousands of Complaints: FDA Inspects Cipla Site in India (Endpoints)
Another manufacturing site belonging to Cipla is under the FDA’s microscope. An FDA inspection of one of Cipla’s manufacturing sites in Pithampur, India unveiled several quality and data observations between Feb.6 and Feb. 23 of this year. According to the 483 report, the manufacturing site received over 3,000 complaints between 2020 and 2022. The FDA’s report also stated that 266 complaints were also received this year and are still under investigation.
According to the FDA report, 91% of the complaints were related to product performance. However, a member of staff told inspectors that there are “adequate controls in place” and no risks to quality or patient safety.
Indian Pharma Firm Venus Remedies Marketing Approval for Cancer Drugs in Uzbekistan, Palestine (BioSpectrum Asia)
Indian pharmaceutical company Venus Remedies has received marketing authorisation for its generic cancer drugs from Uzbekistan and Palestine. Having over 800 marketing authorisations worldwide, the company is making big strides by now extending its footprint in Central Asia and Middle East with the marketing approval for Carboplatin in Uzbekistan and Docetaxel and Irinotecan in Palestine. Uzbekistan and Palestine have limited access to quality medicines, and Venus Remedies is expected to launch these drugs in the two countries in the next financial year.
