Alembic Pharma Receives USFDA Final Approval for Alcaftadine Ophthalmic Solution

Key Takeaways from the USFDA Approval

• Alembic Pharmaceuticals has received USFDA approval for Alcaftadine Ophthalmic Solution, expanding its product portfolio in the ophthalmic category.
• The approval represents a significant milestone for Alembic as it continues to enhance its presence in the global pharmaceutical market.
• With this approval, Alembic now has a total of 216 ANDA approvals from the USFDA, including 189 final approvals and 27 tentative approvals.

As per a stock exchange filing, the product is therapeutically equivalent to the reference listed drug product (RLD), Lastacaft solution 0.25%, manufactured by AbbVie Inc., according to the stock exchange filing. The Alcaftadine Ophthalmic Solution is used for temporarily relieving itchy eyes due to allergens like pollen, ragweed, grass, animal hair, and dander.

Alembic Pharmaceuticals has been a frontrunner in health care since its inception in 1907, emerging as a firm committed to quality and innovation. With state-of-the-art research and manufacturing facilities meeting stringent regulatory standards, including the USFDA, the company operates in several countries.

After this approval, Alembic now has 216 ANDA approvals by the USFDA, which includes 189 final approvals and 27 tentative approvals. In over 5,000 generalised activities, the marketing team makes sure that its brands are among the most recognisable among health professionals and patients. 

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited, founded in 1907, is a research-driven pharmaceutical company based in India. It is publicly listed and produces generic medicines for global markets. Alembic's advanced research and manufacturing facilities are approved by regulators in several developed countries, including the USFDA. The company is a leader in branded generics in India, with a marketing team of over 5,000 promoting its well-known products to doctors and patients across the country.

Key Takeaways from the Debut

• The IPO of Diffusion Engineers saw strong demand, being subscribed 54.24 times, with a price band set between Rs 159 and Rs 168 per share.
• Funds raised will be allocated for expanding existing manufacturing units, setting up new facilities, working capital, and general corporate needs.
• The company's focus lies in manufacturing specialised industrial equipment like welding consumables and wear plates, with a focus on innovation to enhance wear resistance and reduce production costs.

The scrip was listed at Rs 193, exhibiting a premium of 14.88% to the issue price on NSE.

The IPO comprised a fresh issue of 9,405,000 equity shares of Rs 10 face value. The initial public offer (IPO) of Diffusion Engineers was subscribed 54.24 times. The issue opened for bidding on 26 September 2024 and was closed on 30 September 2024. The price band of the Diffusion Engineers IPO was fixed between Rs 159 and Rs 168 per share.

Out of the total funds from the fresh issue, around Rs 71.38 crore will go towards expanding the existing manufacturing facility (Unit IV) at Khapri (Uma) in Nagpur; Rs 30.385 crore will be used to build a new manufacturing facility at Hingna in Sonegaon District, Maharashtra, Rs 22 crore will be allocated for working capital needs; and the remaining amount will be used for general corporate purposes.

About Diffusion Engineers

Diffusion Engineers, led by Prashant Garg, specialises in manufacturing industrial components such as welding consumables, wear-resistant plates, and heavy machinery tailored for key industries. The firm offers advanced repair solutions and surface treatment processes designed to extend the lifespan of machinery components, reducing wear and tear, improving durability, and cutting down on operational costs. In addition to manufacturing, Diffusion Engineers provides reconditioning services and trades in specialised welding and cutting equipment.

Key Takeaways from HDFC Bank’s Financial Update:

• HDFC Bank's advances under management reached Rs 26,335 billion, up 8% a year ago and a 2.3% rise from June 2024.
• Total gross advances stood at Rs 25,190 billion, up 7.0% from Rs 23,546 billion a year earlier, with Rs 192 billion securitised or assigned during the quarter.
• Deposits were reported at Rs 25,000 billion, a 15.1% growth compared to Rs 21,729 billion a year ago and a 5.1% increase from Rs 23,791 billion at the end of June 2024.
•  Average advances under management for the quarter were Rs 25,630 billion, reflecting a 10.2% growth year-on-year, while the liquidity coverage ratio averaged around 127%.

During the quarter, retail loans grew by approximately Rs 338 billion, while commercial and rural banking loans increased by around Rs 380 billion. However, corporate and other wholesale loans decreased by Rs 133 billion compared to June 2024.

The bank's total gross advances were about Rs 25,190 billion, up 7.0% from Rs 23,546 billion a year ago. The bank also securitised or assigned loans worth Rs 192 billion during the quarter.

In terms of deposits, HDFC Bank reported Rs 25,000 billion as of September 30, 2024, which is a 15.1% growth compared to Rs 21,729 billion a year ago and a 5.1% increase from Rs 23,791 billion at the end of June 2024. CASA (Current Account Savings Account) deposits stood at Rs 8,835 billion, rising 8.0% from Rs 8,177 billion a year ago, while time deposits increased by 19.3% to Rs 16,165 billion.

The average advances under management for the September quarter were Rs 25,630 billion, reflecting a 10.2% growth year-on-year. The bank's liquidity coverage ratio averaged around 127% for the quarter.

About HDFC Bank Limited:

HDFC Bank Limited was established in August 1994, with its headquarters in Mumbai, India. It began operations as a Scheduled Commercial Bank in January 1995. On April 4, 2022, a merger was announced between HDFC Bank and HDFC Limited, India's largest housing finance company. HDFC Limited has built a strong reputation over 45 years, offering a wide range of housing finance products. This merger allows HDFC Bank to provide seamless home loan services as part of its extensive product offerings, serving customers in urban, semi-urban, and rural areas.

As of August 31, 2024, HDFC Bank has a distribution network that includes 8,919 branches and 21,031 ATMs or cash recycling machines across 3,836 cities and towns. The bank also operates internationally with branches in Hong Kong, Bahrain, and Dubai, as well as an IFSC Banking Unit in Gujarat. Additionally, it has representative offices in Kenya, Abu Dhabi, Dubai, London, and Singapore, which were previously offices of HDFC Limited. These offices help facilitate housing loans in India and assist customers in purchasing properties in the country.

Key Takeaways from the Acquisition 

• Cyient DLM Limited has brought in a 100% stake in Altek Electronics through its wholly owned subsidiary Cyient DLM Inc., indisputably enhancing Cyient's business within North America.
• Altek Electronics, an electronic manufacturing services (EMS)-related company in the U.S., had 37 million dollars in turnover in 2023, with a multi-sector pattern of clientele including the medical, industrial, and defence sectors.
• With this acquisition comes certain assurances in the perspective of synergies, which strategically position Cyient DLM in the industrial, medical, and defence sectors.

Altek Electronics, headquartered in Connecticut, USA, is known for providing services such as printed circuit board assemblies (PCBA) and upper-level assembly across various industries. With a turnover of USD 37.2 million in 2023, the acquisition aims to create growth synergies for Cyient DLM’s future expansion in key sectors.

The deal is structured as an enterprise value transaction on a debt-free, cash-free basis. The upfront payment is USD 23.4 million, with an additional earnout of up to USD 5.8 million based on Altek’s performance.

About Cyient DLM Limited

Established in 1993, Cyient DLM (NSE: CYIENTDLM) is a leading provider of integrated electronics manufacturing solutions. Throughout the product life cycle, integration combines design-led manufacturing (DLM) with engineering and R&D capacity. Specialised in high-reliability electronic systems applied in safety-critical industries, it extends design, manufacturing, testing, and certification support to deliver the highest standards of performance, safety, and reliability. Cyient customers are in the aerospace & defence, industrial, and medical & healthcare segments.

About Altek Electronics

Altek Electronics is a leading electronics contract manufacturer based in Torrington, Connecticut. With over 50 years of expertise in electronic assembly, Altek specializes in high-mix and low-to-medium volume PCB assemblies across a variety of industries, including medical, industrial, aerospace, and defence; it has developed a reputation for exceptionally delivering quality, reliability, and customer service.