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- Indoco Remedies received final FDA approval for its generic lacosamide oral solution USP 10 mg/mL, equivalent to UCB's Vimpat oral solution. - The approved medication treats partial-onset seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy aged 4 years and above. - The approval strengthens Indoco's presence in the US generics market, particularly in the neurology segment, supporting the company's commitment to global healthcare delivery. - Indoco operates as a fully integrated pharmaceutical company with US$180 million turnover and over 6,000 employees including 400 skilled scientists.
- Indoco Remedies' active pharmaceutical ingredients manufacturing facility at Patalganga completed US FDA inspection with zero Form 483 observations, demonstrating exceptional regulatory compliance. - The successful inspection reflects the company's commitment to quality standards and operational excellence in pharmaceutical manufacturing processes. - Indoco operates as a fully integrated research-oriented pharmaceutical company with $180 million turnover and over 6,000 employees globally. - The company maintains 11 manufacturing facilities approved by major regulatory authorities including USFDA and UK-MHRA, serving both domestic and international markets.
- Indoco Remedies has secured final US FDA approval for its Abbreviated New Drug Application (ANDA) for allopurinol tablets USP 200 mg, a generic equivalent to Casper Pharma's Zyloprim. - Allopurinol is primarily used to prevent or lower high uric acid levels in the blood, including excess levels caused by cancer medicines or in patients with kidney stones. - The approved generic will be manufactured at Indoco's Goa facility in India, strengthening the company's position in the US pharmaceutical market and supporting its global growth strategy.
- Gujarat-based Allchem Lifescience has filed preliminary IPO papers with SEBI, seeking to raise ₹190 crore through fresh equity shares and an offer for sale of 71.55 lakh shares by promoters. - The company specializes in manufacturing API intermediates and piperazine derivatives critical for drugs like quetiapine, with ₹130 crore of proceeds earmarked for debt repayment. - Allchem has demonstrated strong financial growth with revenue CAGR of 12.75% and profit CAGR of 28.65% between FY22-24, serving 214 customers across 22 countries globally.
- Indoco Remedies received US FDA approval for its generic Cetirizine Hydrochloride Tablets USP, 10 mg (OTC). - The generic drug is equivalent to Johnson & Johnson's Zyrtec Allergy Tablets, 10 mg, offering a more affordable option. - Cetirizine is commonly used to alleviate symptoms associated with hay fever and various allergic conditions. - The manufacturing of the tablets will occur at Indoco's facility in Verna Industrial Area, Goa, India.
