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Latest news about Concord Biotech

Concord Biotech Completes EU GMP Inspection at Limbassi API Facility Aug 21, 2025

Concord Biotech Limited has successfully completed a European Union Good Manufacturing Practice (EU GMP) inspection at its Active Pharmaceutical Ingredient (API) facility in Limbassi. The inspection, conducted from August 18 to August 21, 2025, was the first EU GMP inspection at this site. This achievement is expected to enhance the company's global footprint, enable expansion into EU markets, and strengthen its regulatory compliance. Concord Biotech views this as a validation of their commitment to quality standards and operational excellence.

Concord Biotech Reports Q1 Results: Revenue Dips 5% Amid Customer Procurement Lumpiness Aug 18, 2025

Concord Biotech Reports Q1FY26 Results: Revenue Down 5%, EBITDA Declines 24% Aug 13, 2025

Concord Biotech Targets 25% Annual Growth, Releases Q1 FY26 Earnings Call Recording Aug 12, 2025

Concord Biotech Reports Mixed Q1 Results with 5% Revenue Decline, Expands US Operations Aug 10, 2025

More news about Concord Biotech

26Jul 25

Concord Biotech Successfully Completes Russian GMP Inspection at Gujarat API Facility

Concord Biotech Limited successfully completed a Russian Good Manufacturing Practice (GMP) inspection at its Active Pharmaceutical Ingredient (API) manufacturing facility in Dholka, Gujarat. The inspection, conducted from July 22 to July 25, 2025, evaluated the company's manufacturing processes and facilities. This achievement demonstrates Concord Biotech's commitment to maintaining high standards of quality, safety, and regulatory compliance. The successful inspection could potentially open new opportunities for the company in the Russian pharmaceutical market and reinforces its position as a reliable API manufacturer.

22Jul 25

Concord Biotech Expands Operations with New Subsidiary Concord Lifegen Limited

Concord Biotech Limited has incorporated a wholly-owned subsidiary, Concord Lifegen Limited, with an authorized and issued share capital of Rs. 1,00,000. The new entity will focus on marketing, sales, and distribution of pharmaceutical products. Concord Biotech has invested Rs. 1,00,000 for 100% equity ownership, with shares to be allotted within 90 days. The subsidiary aims to execute sales strategies, ensure regulatory compliance, handle logistics, and maintain transparent reporting.

22Jul 25

Concord Biotech Establishes Wholly Owned Subsidiary for Pharmaceutical Marketing and Distribution

Concord Biotech Limited has incorporated a wholly owned subsidiary, Concord Lifegen Limited, on July 21, 2025. The new entity will manage marketing, sales, and distribution of pharmaceutical products. Concord Biotech invested Rs. 1,00,000 for 100% ownership of 10,000 equity shares at Rs. 10 each. The subsidiary aims to enhance commercial efficiency and strengthen Concord Biotech's presence in the biopharmaceutical industry. Concord Lifegen Limited will focus on targeted sales strategies, regulatory compliance, logistics, and customer support across domestic and international markets.

18Jul 25

Concord Biotech's Dholka API Facility Successfully Passes EU GMP Inspection

Concord Biotech Limited announced the successful completion of a European Union Good Manufacturing Practice (EU GMP) inspection at their Active Pharmaceutical Ingredient (API) manufacturing facility in Dholka, Gujarat. The inspection, conducted from July 14 to 18, 2025, validates the company's adherence to European quality and safety standards. This achievement potentially opens up opportunities for Concord Biotech to expand its presence in the European pharmaceutical market and demonstrates its ability to meet international regulatory requirements.

04Jul 25

NCLT Grants Concord Enviro Systems 60-Day Extension for Settlement Talks with Subsidiary

The National Company Law Tribunal (NCLT) has given Concord Biotech a 60-day extension to engage in settlement discussions with one of its units. This development indicates ongoing disputes between the parent company and its subsidiary, with the extension providing an opportunity for out-of-court resolution. The specific timeframe underscores the urgency of the matter, and the outcome of these talks could have significant implications for Concord Biotech's operations and financial standing.

24Jun 25

Concord Biotech's Dholka API Plant Passes U.S. FDA Inspection with Flying Colors

Concord Biotech Limited's Active Pharmaceutical Ingredient (API) manufacturing facility in Dholka, Gujarat, has successfully passed a U.S. Food and Drug Administration (FDA) inspection with no observations. This outcome indicates the facility's compliance with FDA's quality and safety standards, potentially strengthening the company's position in the global pharmaceutical market, especially in the United States. The clean inspection report demonstrates Concord Biotech's commitment to maintaining high-quality standards and regulatory compliance in API manufacturing.

30May 25

Concord Biotech's Q4 Net Profit Soars to ₹1.4 Billion, Announces ₹10.70 Dividend

Concord Biotech's Q4 results show significant growth with net profit reaching ₹1.40 billion, up 44% year-over-year. Revenue increased by 34.4% to ₹4.30 billion. The company's board has recommended a dividend of ₹10.70 per equity share.

29May 25

Concord Biotech Reports Robust Q4 Performance with Surge in Profits and Revenue, Recommends Dividend

Concord Biotech has reported impressive Q4 financial results with significant growth across key metrics. The company's EBITDA increased to ₹1.90 billion from ₹1.34 billion year-over-year, with EBITDA margin expanding to 44.30%. Net profit rose to ₹1.40 billion, up from ₹972.00 million in the previous year. Revenue reached ₹4.30 billion, showing robust growth from ₹3.20 billion last year. The company has also recommended a dividend of ₹10.70 per equity share.

05May 25

Concord Biotech's Dholka Facility Receives Form 483 After USFDA Inspection

Concord Biotech's Dholka facility underwent a USFDA inspection from April 28 to May 2, 2025. The inspection concluded with the issuance of a Form 483 containing four observations. While the specific nature of the observations remains undisclosed, the company is expected to respond with corrective actions to address the FDA's concerns.

02May 25

Concord Biotech's Dholka API Facility Receives FDA Form 483 After Inspection

Concord Biotech Limited's API facility in Dholka, Gujarat, underwent a USFDA inspection from April 28 to May 2, 2025. The inspection concluded with a Form 483 containing four observations, which the company claims are procedural and not related to data integrity. Concord Biotech plans to respond to the USFDA within the required timeframe and is confident in addressing the observations quickly.

09Apr 25

Concord Biotech Secures USFDA Approval for Teriflunomide Tablets, Eyeing $402.00 Million US Market

Concord Biotech Limited has received final USFDA approval to market Teriflunomide Tablets in 7 mg and 14 mg strengths for treating relapsing forms of multiple sclerosis. The US market for this drug is estimated at $402 million, with a global market of $908 million. This approval demonstrates Concord Biotech's capability in developing complex generic drugs and positions the company for expansion in the US pharmaceutical market.

08Apr 25

Concord Biotech Secures FDA Approval for Teriflunomide Tablets, Eyeing $402 Million US Market

Concord Biotech Limited has received final approval from the USFDA to market Teriflunomide tablets in 7 mg and 14 mg strengths for treating relapsing forms of multiple sclerosis. The U.S. market for this drug is valued at approximately $402 million, with a global market of $908 million. This approval marks a significant milestone for the company's expansion into the U.S. pharmaceutical market.

25Mar 25

Concord Biotech Launches Injectable Production at New Valthera Facility

Concord Biotech Limited has successfully commissioned and commenced injectable production at its new Unit-4 manufacturing facility in Valthera on March 25, 2025. The state-of-the-art facility, designed to meet international standards, is equipped with advanced technology for high-quality injectable products. This strategic expansion is expected to enhance the company's manufacturing capabilities and market position in the pharmaceutical sector.

20Feb 25

Concord Biotech Strengthens Global Standing with Successful MFDS Inspection

Concord Biotech Limited successfully completed an inspection by the Ministry of Food and Drug Safety (MFDS) at its Manufacturing Unit I in Dholka, Gujarat. The inspection, conducted from February 18 to February 20, 2025, focused on the company's API facility. This achievement is expected to reinforce Concord Biotech's quality assurance standards, potentially enhance its access to global markets, and strengthen its position in the biotech industry.