Havix, Subsidiary of Senores Pharmaceuticals, Completes USFDA Inspection with 3 Minor Observations 1 day ago Yesterday
Senores Pharmaceuticals' subsidiary, Havix Group Inc., completed a USFDA inspection at its Hoschton, Georgia facility from July 21-25, 2025. The inspection resulted in three Form 483 observations, described as procedural and minor. Havix has 15 days to respond to these observations and intends to address them within the given timeframe.
Senores Pharmaceuticals Reports 72% Revenue Growth in Q1FY26 with Strong Performance Across Segments 5 days ago
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More news about Senores Pharmaceuticals
06May 25
Senores Pharmaceuticals Expands Portfolio with Acquisition of Topiramate ANDA from Wockhardt
Senores Pharmaceuticals Limited has acquired the ANDA for Topiramate HCl tablets from Wockhardt Limited through its US subsidiary. The acquisition includes FDA-approved tablets in four strengths, targeting a $111.47 million market as of December 2024. Funded by IPO proceeds, this move aligns with the company's strategic objectives and strengthens its position in epilepsy and migraine treatments in the US market.
05May 25
Senores Pharmaceuticals Expands Portfolio with Acquisition of Topiramate ANDA
Senores Pharmaceuticals Limited (SPL) has acquired the Abbreviated New Drug Application (ANDA) for Topiramate HCl tablets from Wockhardt Limited on May 5, 2025. The acquisition covers tablet strengths of 25, 50, 100, and 200 mg. The US market size for Topiramate tablets was approximately $111.47 million as of December 2024. The acquisition will be funded using IPO proceeds and aligns with SPL's strategy to expand in the US pharmaceutical market, particularly in neurology. SPL currently has 61 ANDAs, 22 CMO/CDMO commercial products in the USA, and over 260 product registrations in emerging markets.
12Mar 25
Senores Pharmaceuticals Strengthens Hold on Havix Group with 3.73% Stake Acquisition
Senores Pharmaceuticals Limited is set to acquire an additional 3.73% stake in its US-based subsidiary, Havix Group Inc. (Aavis Pharmaceuticals), for USD 1.35 million. This move will increase Senores' ownership from 51.23% to 54.96%. Havix Group, founded in 2015, has shown significant growth with its turnover rising from USD 7.34 million in FY2022 to USD 14.44 million in FY2024. The acquisition, subject to regulatory approvals, is expected to complete within 10 days of the Share Purchase Agreement execution.
11Mar 25
Senores Pharmaceuticals Boosts Stake in Havix Group, Strengthening Its US Presence
Senores Pharmaceuticals Limited plans to acquire an additional 3.73% stake in its US-based subsidiary, Havix Group Inc., increasing its ownership from 51.23% to 54.96%. The acquisition involves 8,454 equity shares at $160 per share, to be completed within 10 days of the share purchase agreement signed on March 11, 2025. Havix Group, specializing in finished formulations, has shown strong financial growth with its turnover nearly doubling from $7.3 million in FY 2022 to $14.4 million in FY 2024.
04Mar 25
Senores Pharmaceuticals Acquires 14 ANDAs from Dr. Reddy's, Eyes $421 Million US Market Opportunity
Senores Pharmaceuticals has acquired 14 Abbreviated New Drug Applications (ANDAs) from Dr. Reddy's Laboratories, including 13 FDA-approved and 1 pending approval. The acquisition targets a US market opportunity of $421 million, with potential for $1.13 billion. The company will fund this using IPO proceeds. The acquired portfolio spans various therapeutic areas and includes controlled substances, enhancing Senores' product offerings in the US and other markets.
27Feb 25
Senores Pharmaceuticals Expands API Manufacturing with New Gujarat Facility
Senores Pharmaceuticals Limited has launched its second Active Pharmaceutical Ingredient (API) manufacturing facility in Rajpur, Kadi, Mehsana, Gujarat. The new greenfield plant, spanning 230,000 sq. ft. with an installed capacity of ~100 Metric Tons per Annum, began operations on February 26, 2025. This strategic expansion aims to enhance the company's API manufacturing capabilities, broaden its product offerings, and strengthen its position in regulated markets, particularly in the CDMO/CMO business segment.
26Feb 25
Senores Pharmaceuticals Expands API Production with New Gujarat Facility
Senores Pharmaceuticals Limited has inaugurated its second Active Pharmaceutical Ingredient (API) manufacturing facility in Rajpur, Kadi, Mehsana, Gujarat. The new greenfield plant, spanning 230,000 sq. ft. with an installed capacity of ~100 Metric Tons per Annum, commenced operations on February 26, 2025. This expansion is expected to enhance Senores' product offerings, competitiveness in regulated markets, and strengthen its position in the CDMO/CMO sector. The company, with existing operations in the US and India, views this as a strategic move to broaden its capabilities and market reach.
21Feb 25
Senores Pharmaceuticals Expands Portfolio with Roflumilast ANDA Acquisition
Senores Pharmaceuticals Limited (SPL) has acquired the ANDA for Roflumilast tablets from Breckenridge Pharmaceutical, Inc. The acquisition, announced on February 20, 2025, includes 250 mcg and 500 mcg strengths of the USFDA-approved tablets. Roflumilast is used for treating severe COPD associated with chronic bronchitis. The US market size for Roflumilast ranges from $32 million to $46 million. SPL plans to manufacture the tablets at its US site, expanding its portfolio into specialty distribution and the chronic bronchitis therapy area. The acquisition is funded through IPO proceeds.
20Feb 25
Senores Pharmaceuticals Expands Portfolio with Acquisition of Roflumilast ANDA
Senores Pharmaceuticals Limited has acquired the ANDA for Roflumilast tablets (250 mcg and 500 mcg) from Breckenridge Pharmaceutical, Inc. The acquisition, announced on February 20, 2025, aims to strengthen SPL's position in the US pharmaceutical market. Roflumilast is used for reducing COPD exacerbation risks. The US market for Roflumilast is valued at $32-46 million. Manufacturing will be done at SPL's US-based, USFDA-approved facility. The acquisition aligns with SPL's strategy to enter niche generic formulations markets and will be funded through IPO proceeds.