India has initiated an anti-dumping investigation into imports of Penicillin G and its salts from China after domestic manufacturer Lyfius Pharma alleged the imports were causing material retardation to the industry.

The company has sought imposition of anti-dumping duties, the Directorate General of Trade Remedies, under the Ministry of Commerce and Industry, said in a notification initiating the investigation.

The Aurobindo Pharma subsidiary began manufacturing Penicillin G more than two years ago under the government’s production linked (PLI) scheme and with it revived production of the beta-lactam antibiotic in the country after about three decades.

Stating that it is the sole eligible producer of the product under consideration (PUC) in India and there are no other domestic manufacturers, Lyfius Pharma, in the application, said India used to previously manufacture Penicillin G before sustained influx of imports ceased domestic production.

The PUC, under the investigation, covers Penicillin G in all forms, grades, strengths and concentrations, along with its salt forms, whether or not conforming to pharmacopoeial standards, and in both solid and liquid forms. The product is used as a key starting material (KSM) and active pharmaceutical ingredient (API) in the manufacture of various medicines used to treat bacterial infections, including pneumonia, dental infections, diphtheria and meningitis, the DGTR said.

The DGTR, which agreed to the company’s suggestion for 2025-26 as the period of investigation, said there is sufficient prima facie evidence that the PUC is being dumped into the domestic market by exporters from China.

Lyfius Pharma said it has not been able to achieve production and sales as expected and forced to reduce its prices to match the landed price of imports.

Prime Minister Narendra Modi inaugurated the Lyfius Pharma’s 15,000 tonnes Pen G facility in Kakinada, Andhra Pradesh in October 2024. Aurobindo Pharma had said the facility represented a strategic ₹2,500 crore investment under the Centre’s PLI scheme for pharmaceutical sector.

India manufactured Penicillin G until the late 1980s. However, following globalisation, imports led to closure of all plants producing the antibiotic in the country. In March 2024, then Union Minister for Chemicals and Fertilisers and Health and Family Welfare Mansukh Mandaviya said the government was working on bringing back production of Penicillin G in India after three decades.

Earlier this year, Aurobindo Pharma said it expected to produce more than 10,000 metric tonnes on annualised basis over the following 12 months.

Aurobindo Pharma subsidiary CuraTeQ Biologics has received notice of compliance (NOC) from Health Canada’s Biologics and Radiopharmaceutical Drugs Directorate for Dyrupeg, its pegylated filgrastim biosimilar version.

A notice of compliance from Health Canada is issued to a drug manufacturer after a successful review, confirming the product meets regulatory standards for safety, efficacy and quality under the Food and Drug Regulations.

For Dyrupeg, the NOC specifically indicates Health Canada has verified high similarity to an approved reference biologic drug, with no clinically meaningful differences in terms of safety, PK/PD or quality attributes, Aurobindo Pharma said on Friday.

In 2025, Dyrupeg had received marketing authorisation in the European Union from the European Commission and from MHRA, UK. There are three other biosimilar applications from CuraTeQ Biologics seeking marketing authorisation that are currently under review with Health Canada, it said.

The U.S.Food and Drug Administration has issued five observations to Aurobindo Pharma subsidiary APL Healthcare’s unit in Andhra Pradesh.

The U.S.FDA inspected Unit-IV of APL Healthcare in SPSR Nellore District, Andhra Pradesh, from December 8 to 17 and issued a Form 483 with five observations. Aurobindo Pharma said the observations are procedural in nature and “we will respond to the U.S.FDA within the stipulated timelines.”

The company is committed to maintaining the highest quality manufacturing standards at all its facilities worldwide, it said following the development, which comes close on the heels of the three observations U.S. FDA issued to the active pharmaceutical ingredients (API) manufacturing facility of another subsidiary, Apitoria Pharma, in Hyderabad.