New Delhi, May 16 (IANS) Emcure Pharmaceuticals on Saturday said the United States Food and Drug Administration (US FDA) completed a current Good Manufacturing Practices (cGMP) inspection at its formulations manufacturing facility in Sanand, Ahmedabad, Gujarat, and issued a Form 483 with seven observations.The inspection was conducted between May 6 and May 15, 2026, at the company’s facility located in the G.I.D.C. industrial area in Taluka-Sanand, Ahmedabad. According to the company, the obse…
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New Delhi, May 3 (IANS) Pharmaceutical major Alkem Laboratories has come under regulatory scrutiny after the United States Food and Drug Administration (USFDA) issued inspectional observations at its manufacturing facility in Amaliya, Daman, following a recent audit.The inspection, conducted over 12 days from April 20 to May 1, concluded with the issuance of a Form 483, in which the US regulator flagged seven observations.A Form 483, formally known as a “Notice of Inspectional Observations,”…
New Delhi, March 21 (IANS) India’s pharmaceutical industry has evolved into a globally integrated and policy-supported system, ranking third globally by volume and 11th by value, with more than 3,000 companies and 10,500 manufacturing units, an official factsheet showed on Saturday.The domestic pharmaceutical market, valued at $60 billion, is projected to reach $130 billion by 2030.According to the Economic Survey 2025-26, in FY25, the sector’s annual turnover reached Rs. 4.72 lakh crore, wi…
New Delhi, March 17 (IANS) Aurobindo Pharma on Tuesday said that the US Food and Drug Administration (USFDA) has classified one of its subsidiary units as “Official Action Indicated” (OAI) following an inspection conducted last year.In a regulatory filing, the company said that the USFDA inspected Unit-II of Eugia Pharma Specialities Limited, its wholly-owned subsidiary, located in Bhiwadi, Rajasthan, between November 3 and 14, 2025.At the end of the inspection, the regulator had issued a Fo…
New Delhi, March 8 (IANS) A US-based subsidiary of Cipla has recalled more than 400 cartons of a generic anti-cancer medicine due to a manufacturing issue, according to the US Food and Drug Administration (USFDA).In its latest enforcement report, the US health regulator said that Cipla USA, Inc, based in Warren, New Jersey, is recalling certain batches of Nilotinib Capsules in two strengths — 150 mg and 200 mg.The recall involves 271 cartons of one batch and 164 cartons of another batch of the …
New Delhi, Jan 26 (IANS) Indian drugmakers Sun Pharmaceutical Industries and Cipla have recalled certain products from the US market due to manufacturing-related issues, according to the latest update from the US Food and Drug Administration (USFDA).In its Enforcement Report, the US health regulator said the US-based arm of Mumbai-headquartered Sun Pharma is recalling more than 26,000 bottles of a generic medicine used to treat dandruff and skin conditions that cause inflammation and itching.Sun…
Hyderabad, Jan 21 (IANS) The Telangana government has set the target of attracting $25 billion investment in life sciences in the next five years.The government unveiled Telangana Next-Gen Life Sciences Policy 2026–2030 at Davos with a clear roadmap to position Telangana among the top five global life sciences clusters by 2030.Chief Minister A. Revanth Reddy, who is leading a delegation of ministers and top officials at the World Economic Forum (WEF) annual meeting, released the policy.Industr…
New Delhi, Dec 25 (IANS) Sun Pharma’s US arm, Taro Pharmaceutical Industries, has recalled more than 17,000 units of antifungal over manufacturing issues, the US Food and Drug Administration (USFDA) has said.The Ciclopirox Shampoo — an antifungal medication that treats seborrheic dermatitis (a condition that causes dry, flaky, and itchy skin) — is being recalled due to “failed impurity/degradation specifications”, the USFDA said, in its latest Enforcement Report.The Class II nationwide r…