Torrent Investments Ltd.

New Delhi: As domestic brands in India began introducing their generic versions of key anti-diabetic medicine empagliflozin following the expiry of its patent, the National Pharmaceutical Pricing Authority (NPPA), has fixed the retail prices of the drug combinations and different dosage strengths. Issuing a gazette notification, the Ministry of Chemicals and Fertilizers and the country’s drug price regulator announced that “based on the decision of 132nd Authority meeting dated 29.4.2025 the authority has fixed retail prices of 84 formulations under Drugs (Prices Control) Order, 2013.” The price list attached with the official notification includes around 36 variants of empagliflozin, linagliptin and metformin hydrochloride Fixed-Dose Combinations (FDC) of various brands and manufacturers. Empagliflozin, indicated for Type-2 diabetes, inhibits the release of SGLT2 protein in the kidneys which reduces glucose reabsorption in blood and helps in lowering the blood sugar level of patients. Under the notified list the combination of empagliflozin 12.5mg and metformin hydrochloride 1000mg tablet of Corona Remedies is priced at ₹19.64, while a combination including linagliptin along with these active ingredients of Lupin is priced at ₹22.32. The notified retail prices excludes the applicable Goods and Services Tax (GST) and are applicable to the respective manufacturer and marketer specified in the list. As per a market research firm Pharmarack as of April 2025 the total market of empagliflozin and its related combination is valued around ₹745 crore. Of this, plain empagliflozin and its combination with linagliptin accounts for nearly 86 per cent of the total market. In FY25 empagliflozin plain tablets reported a Moving Annual Turnover of ₹337 crore, reflecting a market share of 45 per cent while its combination version with linagliptin had a MAT value of ₹308 crore and a market share of 41 per cent. Besides this the drug's other combinations such as empagliflozin and metformin reported an annual turnover of ₹102 crore with a 14 per cent market share. The retail price fixation exercise has been undertaken in the aftermath of the expiry of empagliflozin’s patent in March this year followed by a series of generic entrants in the market. In India, the drug patent was owned by Germany-based Boehringer Ingelheim and the drug was marketed under the brand name Jardiance. After the drug went off patent, companies like Alkem and Glenmark launched their generic versions under the brand names ‘Empanorm’ and ‘Glempa’ respectively. Besides them other major generic players like Mankind and USV also joined the fray. For patients, the development gave a major price relief as the generic versions are stated to cost around 80-90 per cent less than the patented version. As per the NPPA price list the innovator's version single tablet is priced at ₹53, whereas the other brands from the license holders Torrent, Cipla and Lupin are priced between ₹46-48 per tablet. While announcing the launch, Rajeev Juneja, Vice Chairman and Managing Director, Mankind Pharma said that, “the company will market its respective brand at ₹5.49 per tablet for the 10 mg variant and ₹9.90 per tablet for the 25 mg variant. The latest monthly progress report of Indian pharma market by Pharmarack suggests that as of April close to 147 brands from 37 companies have forayed in the empagliflozin plain and combinations market, reflecting a two-fold jump from the previous month status of 86 brands and 19 Companies. Under the provisions of Drugs (Prices Control) Order, 2013, the retail price of a new drug is fixed by NPPA and the applicant manufacturer and marketer, are required to sell the new drug within the notified price. By Abhijeet Singh ,

New Delhi: Drugmaker BDR Pharmaceuticals is looking to expand its US footprint through buyouts of manufacturing facilities with an investment of $100 million, its Chairman & Managing Director Dharmesh Shah told ET. The company, which has current revenue of approximately $200 million, is planning to list by 2027, he said. “We are eyeing asset acquisition for manufacturing in the US…We have evaluated a couple of units and we should be deciding on the acquisition in the next three to four months,” said Shah. The planned acquisition will be funded through internal accruals. BDR has a significant portion of its business contributed from value-added CDMO operations focusing on key therapeutic segments such as oncology, critical care, women's healthcare and dermatology. Industry experts said the uncertainty surrounding the US tariffs may prompt many Indian manufacturers to acquire assets in the US that will enable them to avoid significant cost increase they would otherwise incur on exporting the finished drug. “We want to manufacture in the US certain controlled substances and complex molecules. The reason being that the US, if you have to cater to the defense sector, the preference is for the local producer,” said Shah. “We prefer that we have an establishment there and we do the tech transfer and manufacture there and cater locally to the government.” Shah added that the company has been planning this expansion over the last one year. “Our thought process has been there for last one year. US is a big market and local defense buying is also huge. It's always better to produce locally,” he added. “Inorganic definitely helps you to fast track approval,” said Shah. BDR, which has tie-ups with top Indian pharma companies like Dr Reddy’s, Sun Pharma , Cipla , Zydus , and Torrent, is evaluating 200 ANDAs in the US. These include solid dosage and injectables in cardiology, diabetology, pain management, dermatology and HIV. “Around 45% or 80-90 of these ANDAs are going to be commercialised,” said Shah. On the impact of possible tariffs on exports of pharmaceutical products from India, Shah said, “The current geopolitical situations are very uncertain due to a lot of things happening. But the operating cost in the US is very high and the dependence on active raw material is largely on India and China - which is the major cost contributing factor. That's where, with India being a preferred partner, Indian generics don't need to worry about.” India is a major supplier of generic medicines to the US market. Its exports worth about $9 billion in value terms account for 40% of the medicines consumed in the US. “Because there's a huge difference in operating cost as well as the backward integration strength. I don't believe it is in the interest of even the US to make generics expensive.” The company, which is now globally into oncology molecule, is also in the process of setting up a new plant for complex oncological injectable at Halol near Vadodara in Gujarat, where it already has two facilities for complex injectable and oral solid dosage in areas such as anti-inflammatory, antibiotics and others. The company has already started the process for FDA approval and almost seven filings for complex oncology molecules are lined up this year. The company is filing for approval for a new drug delivery system in oncology, for geriatric patients, under 505B2 which is a streamlined FDA drug approval process that allows use of existing data. By Rica Bhattacharyya ,

New Delhi: Pharma companies are expected to stand out in the March 2025 quarter, offering stability amid broader earnings weakness. According to the average of estimates from 4 brokerages, Sun Pharmaceutical, Dr Reddy's Laboratories, and Lupin are set to report healthy growth, driven by strong US portfolios and steady India performance. Cipla and Torrent Pharmaceuticals are likely to show resilience despite margin pressures, while Divi's Laboratories may post moderate gains. Sun Pharma is expected to post a 9 per cent year-on-year revenue growth, supported by its US specialty portfolio and steady growth in chronic therapies in India. However, sequentially, revenue could decline by 4.5 per cent on an average, due to weakness in emerging markets and seasonality. The operating margin before depreciation and amortisation (Ebitda margin) is expected to expand by 115 basis points year-on-year to 26.5 per cent. Divi's revenue and profit may grow by 9 per cent on year. According to analysts, gains from custom synthesis and contrast media could be offset by high base and slow domestic demand projecting Ebitda margin around 32 per cent, down by 23 bpson year. "Sequential decline owes to lower domestic business led by seasonality, while US business will inch up with Lanreotide seeing partial normalisation," said Equirus citing that Q4 was usually weak for Cipla and should show up during this year as well. Cipla may report 10% on year revenue growth, higher from 7.4 per cent last year. It will be driven by stable performance in US generics segment. However, it may fall quarter-on-quarter. "Sequential decline owes to lower domestic business led by seasonality, while US business will inch up with Lanreotide seeing partial normalisation," said Equirus citing that Q4 was usually weak for Cipla and should show up during this year as well. DRL is poised to deliver a standout performance, with revenue projected to grow 18 per cent year-on-year, led by US generics portfolio including gRevlimid. "We expect domestic sales to grow, led by a 6 per cent growth in its organic business and contributions from the in-licensing deals with Sanofi and Bayer," stated Kotak Securities. For Lupin, revenue may rise by 12 per cent on year, driven by US launches such as gXarelto and improved inhalation therapy traction. Domestic growth may be modest due to seasonal softness. Net profit is expected to grow 108 per cent due to low base. Margins may dip sequentially due to higher R&D costs and operating expenses. Torrent could see a rebound in its contract manufacturing business and stable growth in the Indian market. Domestic formulation portfolio continues to be a strong anchor, and analysts note improving visibility in export markets. Analysts remain upbeat on companies with a well-diversified US presence, lean cost structures, and strong domestic execution.