News about "active pharmaceutical ingredient "

Torrent Pharma Recalls Select Semalix Injection Batches Following API-Related Quality Issue

Torrent Pharmaceuticals has initiated a recall of select batches of Semalix Injection 2 mg and 4 mg after certain semaglutide batches failed quality specifications due to an API-related issue.

Active Pharmaceutical Ingredient | 10/07/2026 | By News Bureau

Dr. Reddy's Delays Semaglutide Supplies Following API-Related Quality Issue

Dr. Reddy's Laboratories announces a temporary delay in commercial supplies of semaglutide after identifying an API-related quality issue affecting certain batches. The company is investigating the root cause and has confirmed that patient safety and existing global regulatory filings remain unaffected.

Active Pharmaceutical Ingredient | 09/07/2026 | By News Bureau

La Chandra Pharmalab Secures US FDA Clearance for Gujarat Hormone API Facility

La Chandra Pharmalab has received a US FDA Establishment Inspection Report (EIR) for its Banaskantha hormone API manufacturing facility, reinforcing its position in regulated markets and advancing India's capabilities in hormone API manufacturing.

Active Pharmaceutical Ingredient | 03/07/2026 | By News Bureau |  110

Akums Secures European CEP Approval for Cefpodoxime Proxetil API

Akums Drugs and Pharmaceuticals has received a Certificate of Suitability from the EDQM for its Cefpodoxime Proxetil API, reinforcing the company’s commitment to global quality compliance and enhancing its position as a trusted manufacturing partner for regulated international markets.

Active Pharmaceutical Ingredient | 06/06/2026 | By News Bureau

IOL Chemicals and Pharmaceuticals Reports Q3 and 9M FY26 Results

IOL Chemicals and Pharmaceuticals reported strong Q3 and nine-month FY26 results, with profit before exceptional items rising 39 percent year-on-year, supported by margin expansion and improved operational performance.

Active Pharmaceutical Ingredient | 12/02/2026 | By News Bureau |  166

PharmAla Biotech Australia Ties Up with UK CDMO to Manufacture ALA-002

PharmAla Biotech Australia has contracted a UK-based CDMO to manufacture the drug substance for ALA-002, its patented non-racemic MDMA formulation, ahead of planned phase 2a/2b clinical trials for social anxiety disorder expected to begin in 2026.

Active Pharmaceutical Ingredient | 16/12/2025 | By News Bureau |  254

Eli Lilly Expands USA Manufacturing with Alabama Plant

The site will focus on producing synthetic and peptide-based medicines, including Lilly’s first oral GLP-1 weight-loss therapy, Orforglipron, which the company expects to submit for regulatory approval early next year.

Active Pharmaceutical Ingredient | 11/12/2025 | By Darshana |  153

Sai Life Sciences Completes Phase-II of Production Block 11 at Bidar site

Sai Life Sciences’ Unit IV in Bidar is the company’s flagship manufacturing site, specialising in the production of APIs and advanced intermediates for markets such as the US, EU and Japan.

Active Pharmaceutical Ingredient | 29/08/2025 | By Dineshwori |  447

Torrent Pharma's Vizag API Unit Passes USFDA Inspection with Zero Observation

The US Food and Drug Administration (USFDA) has completed the inspection of Torrent Pharma's API manufacturing facility located in Vizag, Andhra Pradesh.

Active Pharmaceutical Ingredient | 04/08/2025 | By Dineshwori |  953

Monitor NDMA Impurity in Ranitidine Formulation: DCGI Directs Indian Drugmakers

The DCGI has instructed drug controllers of all States and Union Territories to ensure that manufacturers under their jurisdiction monitor the presence of N-Nitrosodimethylamine(NDMA) - a potentially carcinogenic impurity – in the active pharmaceutical ingredient (API) and formulation of the antacid Ranitidine.

Active Pharmaceutical Ingredient | 31/07/2025 | By Dineshwori |  1255