Pharma Exports

US, UK in focus as pharma companies eye $31 billion exports in FY25

Industry also working to pump up business in Africa and Russia, regions battling geopolitical crises

Cipla: Timely new launches, India outperformance key for margin gains

Brokerages maintain add/buy rating on the stock

India raises issue of pharma pricing control in Australia on generic drugs

India has raised the issue of pharmaceutical pricing control in Australia, particularly on generic medicines, during a recent bilateral meeting between the officials of the two countries. The two sides have decided to work closely on timely resolution of market access issues, deepen people-to-people contacts, and create an institutional mechanism for sharing of preferential import data, the commerce ministry said on Saturday. The bilateral trade between the countries declined 7.7 per cent to USD 24 billion in 2023-24 as against USD 26 billion in 2022-23. These issues among others were discussed during the first Joint Committee Meeting (JCM) in Canberra under India-Australia Economic Co-operation and Trade Agreement (Ind-Aus ECTA). "Both the sides while acknowledging the smooth implementation of the ECTA, briefly elaborated on ECTA implementation issues including MRAs (mutual recognition agreements) on organic products, market access issues related to products like okra, pomegranate

Domestic drug firms to witness 8-10% revenue growth in FY25: Report

Revenue growth of leading 25 domestic drug firms is expected to moderate to 8-10 per cent in the next fiscal year, rating agency Icra said on Thursday. The revenue of the companies, which account for 60 per cent of the overall Indian pharmaceutical industry, witnessed an increase of 13-14 per cent in the current fiscal year. Following the high base of 2023-24, the revenue growth momentum from the US and Europe markets is expected to moderate to 8-10 per cent and 7-9 per cent, respectively, Icra said. The markets are expected to witness a year-on-year expansion of 18-20 per cent and 16-18 per cent, respectively, in the current fiscal year, it added. The domestic market, on the other hand, is expected to see a stable growth of 6-8 per cent, while the emerging markets may log an 8-10 per cent rise in FY25, against 16-18 per cent in FY24, the rating agency said. The revenue growth of the sample set companies in the US market in FY24 has been supported by increased new product launches

USFDA nod to Lupin for generic Loteprednol Etabonate ophthalmic suspension

Pharma major Lupin Ltd on Wednesday said it has received approval from the US health regulator to market its generic Loteprednol Etabonate ophthalmic suspension indicated for temporary relief of seasonal allergic conjunctivitis. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Loteprednol Etabonate ophthalmic suspension, 0.2 per cent, Lupin said in a regulatory filing. It is a generic equivalent to the reference listed drug (RLD) Alrex ophthalmic suspension, 0.2 per cent of Bausch & Lomb Inc. The product will be manufactured at Lupin's Pithampur facility in India, the company added. Loteprednol Etabonate ophthalmic suspension, 0.2 per cent, is indicated for the temporary relief of signs and symptoms of seasonal allergic conjunctivitis. It had estimated annual sales of USD 29.1 million in the US market, Lupin said citing IQVIA MAT October 2023 data.

Aurobindo Pharma gets USFDA approval for generic antifungal injection

Aurobindo Pharma Ltd on Wednesday said its wholly-owned arm Eugia Pharma Specialities Ltd has received final approval from the US health regulator to manufacture and market generic Posaconazole injection used to prevent serious fungal infections. The approval by the US Food & Drug Administration (USFDA) is for Posaconazole injection of 300 mg/16.7 mL (18 mg/mL), single-dose vial, Aurobindo Pharma said in a regulatory filing. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Noxafil Injection, 300 mg/16.7 mL (18 mg/mL), of Merck Sharp & Dohme LLC (Merck), it added. "The product is expected to be launched in December 2023," the company said. Posaconazole injection, 300 mg/16.7 mL (18 mg/mL), single-dose vial is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised due to certain conditions, it added. The approved ...

Aurobindo Pharma's new injectable facility get 10 observations from US FDA

"The observations are procedural and will be responded to within the stipulated time," the company stated in a regulatory filing

USFDA pulls up Intas Pharma for manufacturing lapses at Ahmedabad plant

The US health regulator has pulled up Intas Pharmaceuticals for manufacturing lapses, including violation of current good manufacturing practice (CGMP) regulation, at its Ahmedabad-based plant. In a warning letter to the company's CEO and MD Nimish Chudgar, the US Food and Drug Administration (USFDA) has pointed out various manufacturing lapses at the Matoda-Sanand, Ahmedabad-based facility. A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. The USFDA inspected the facility from May 1-12, 2023. "This warning letter summarises significant violations of CGMP regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," it noted. In the warning letter, the health regulator pointed out the company "failed to exercise its responsibility to ensure drug products manufactured

Indian pharma exports to Iran decline thanks to its lower rupee reserves

Indian pharma exports to Iran have declined from $205.1 million in FY20 to $59.14 million in FY23. Iran's rupee reserves have depleted as India ceased oil imports from the country in mid-2019

Centre extends deadline for track and trace system for pharma exports

The extension applies to both Small Scale Industries (SSI) and non-SSI manufactured drugs

Pharma exports likely to touch all-time high of $27 bn in FY23 riding on EU

Better figure expected despite global headwinds; India has so far exported pharma products worth $16.57 bn during April-November this year

Indian pharma exports rise by 4.22% to $14.57 bn during April-Oct

Pharmaceutical exports from India registered a growth of 4.22 per cent to reach USD 14.57 billion during the April-October period despite a negative trend last month, according to a senior official of an export promotion body under Government of India. Udaya Bhaskar, Director General of Pharmaceuticals Export Promotion Council of India (Pharmexcil) which is an organisation under the Ministry of Commerce, said he was hopeful of ending the current fiscal at around USD 27 billion as against USD 24.62 billion during the last financial year. "There was a dip (-0.32 per cent) in July and (-5.45 per cent) and there was 8.47 per cent positive growth in September. I am optimistic that it will be revived in the coming months and may touch USD 27 billion at the end of the fiscal," Bhaskar told PTI. During the same period last fiscal, the exports fetched USD 13.98 billion. USA, Canada and Mexico (NAFTA countries), Europe and Africa account for 67.5 per cent (nearly USD 5 billion) of the total

India's pharmaceutical exports have grown by 138% since 2013-14: Mandaviya

India's pharma exports have increased 138% in April-October 2022-23 compared to the same period of 2013-14, the health minister said

India's pharma exports touch Rs 1.8 trillion in FY22, flat over FY21

India ranks third worldwide for production in terms of volume and 14th by value, says commerce ministry.

Pharma exports touch Rs 1.83 trillion in 2021-22: Commerce ministry

The exports in 2021-22 sustained a positive growth despite the global trade disruptions and drop in demand for COVID related medicines

Indian companies stay put in Russia but pharma exports could be hit

Executives at Indian pharma companies Torrent Pharmaceuticals and Zydus Lifesciences said they saw little or no impact on sales due to the Ukraine conflict.

Russia-Ukraine crisis: Indian pharma exporters in wait and watch mode

An official of Dr Reddy's Laboratories said they are closely monitoring the developments and ensuring the well-being of their staff in that region is the first and foremost priority

Sluggish exports may cap pharma YoY revenue growth in FY22, says Crisil

Revenue growth of India's pharmaceutical sector is expected to "moderate" to 9 per cent in FY22, as compared with a healthy rise of 12.5 per cent during the previous fiscal, Crisil said

India's exports rise nearly 40% in second week of August, shows data

Engineering goods witnessed the maximum increase during the week, owing to higher demand from US and Italy

Indian pharma exports grow at 18% to $24.44 billion in FY 21 from $20.58 bn

Pharma exports from India witnessed over 18 per cent growth to USD 24.44 billion during the last financial year against USD 20.58 billion in FY20