Alembic Pharma Gets USFDA Nod for Paliperidone Extended-Release Tablets

Key Takeaways from Alembic Pharma USFDA Nod for Paliperidone Extended-Release Tablets:

• Alembic Pharma has received final approval from the US FDA for Paliperidone Extended-Release Tablets.
• The approved tablets come in 1.5 mg, 3 mg, 6 mg, and 9 mg dosages.
• The approval pertains to an Abbreviated New Drug Application (ANDA) that is therapeutically equivalent to Janssen Pharmaceuticals' Invega Extended-Release Tablets.
• The estimated market for these tablets is approximately $48 million for the year ending June 2024.

Paliperidone is an atypical antipsychotic medication used to treat schizophrenia and schizoaffective disorder. The market for these tablets is estimated to be around $48 million for the year ending June 2024.

This approval is for an Abbreviated New Drug Application (ANDA) that is considered therapeutically equivalent to the reference drug, Invega Extended-Release Tablets, produced by Janssen Pharmaceuticals.

With this latest approval, Alembic now has a total of 215 ANDA approvals from the USFDA, including 187 final approvals and 28 tentative approvals. 

About Alembic Pharmaceuticals Limited:

Alembic Pharmaceuticals Limited is a pharmaceutical company focused on research and development, with a history dating back to 1907. Based in India, Alembic is publicly traded and produces a wide range of generic medications that are sold globally. Their advanced research and manufacturing facilities meet the standards of several regulatory bodies, including the US FDA. Alembic is a leading player in the branded generics market in India, with a marketing team of over 5,000 people who help promote their well-known brands to doctors and patients.

Key Takeaways from Saksoft’s Acquisition: 

• Saksoft is acquiring Ceptes Software Private Limited, a global Salesforce service provider.
• The total cash consideration for the acquisition is up to Rs. 61.50 crores, including an upfront payment of Rs. 31.05 crores.
• The acquisition will enhance Saksoft's Salesforce-related capabilities and expand its access to enterprise customers.
• The transaction is expected to be finalised within the next four weeks.

The total cash consideration for the acquisition is expected to be up to Rs. 61.50 crores, with an upfront payment of Rs. 31.05 crores and additional earnout consideration based on performance over the next 24 months. 

Upon completing the payment, Saksoft will own 100% of Ceptes. The transaction is anticipated to be finalised within the next four weeks.

About Saksoft Limited:

Saksoft Limited specialises in business intelligence and information management solutions, primarily for mid-sized companies in the USA and UK. Founded in 1999 by Autar Krishna and his son Aditya Krishna, the company is a top digital transformation partner for clients around the world. Its services include application development, testing and quality control, as well as solutions related to cloud computing, mobile technology, and the Internet of Things (IoT), along with information management and business intelligence solutions. With nearly 25 years of experience, the company is dedicated to delivering innovative solutions that empower clients to succeed in a competitive landscape.

About Ceptes Software Private Limited:

Founded in 2010, Ceptes Software Private Limited is a global provider of Salesforce services, specialising in consultation, digitalization, and innovation. Based in Bengaluru, India, with offices in Dallas and Dubai, Ceptes has grown from two employees to over 250, serving more than 150 global clients. The company offers various services, including application development and cloud solutions, and has achieved notable milestones such as becoming a Salesforce Summit Partner and winning multiple innovation awards. In 2024, Ceptes received ISO 27001 certification and launched new AI-driven products. Committed to customer satisfaction and continuous improvement, Ceptes is focused on driving success for its clients in the tech landscape.

Key Takeaways from OLA Electric's PLI Certification Announcement:

• OLA Electric’s S1 X 2 kWh gets certification under the Production Linked Incentive (PLI) Scheme for the automobile and auto components sector.
• The S1 X 2 kWh meets the government’s requirement for at least 50% localization of parts.
• Ola Electric is eligible for incentives for up to five years, starting from fiscal year 2024, ranging from 13% to 18% of the sales value.
• Ola Electric has also received certification for its battery storage capacity under the PLI scheme.

The S1 X 2 kWh scooter has met the government’s requirement for at least 50% localisation of parts, which is a key criterion for the PLI scheme. 

The certification was awarded by the Automotive Research Association of India (ARAI) after thorough testing. With this certification, Ola Electric is eligible for financial incentives for up to five years, starting from the fiscal year 2024. The incentives will range from 13% to 18% of the sales value of the products.

The company has also been awarded 20GWh capacity by the government under its PLI scheme for Advanced Chemistry Cell (ACC) Battery storage in March 2022. 

About Ola Electric Limited:

Ola Electric Mobility Limited is a leading electric vehicle (EV) manufacturer in India, focusing on integrating technology and manufacturing for EVs and their parts, including batteries. The main operations take place at the Ola Futurefactory, where they produce EVs and key components like battery packs, motors, and vehicle frames. 

Ola conducts research and development in India, the UK, and the US, aiming to innovate in EV products and core components. They are also building a large EV hub in Tamil Nadu, which includes the Ola Futurefactory and a new Gigafactory for battery production. This hub is supported by the Battery Innovation Centre in Bengaluru, which focuses on improving battery technology.

Ola Electric has a direct sales network with over 750 experience centres across India, along with a strong online presence, making it the largest network of company-owned automotive experience centres in the country.

Key Takeaways from the Announcement

• Purvah Green Power Private Limited established a wholly-owned subsidiary named KUS Renewable Private Limited (KRPL) on September 26, 2024.
• KRPL will explore opportunities in the renewable power sector.
• KRPL is fully owned by Purvah Green Power, with 100% of its shareholding held by the parent company.

As per the stock exchange filing, the new subsidiary, KRPL, is fully owned by Purvah Green Power, meaning 100% of its shareholding is held by Purvah. The paid-up capital of KRPL is ₹1,00,000, and no governmental or regulatory approvals were required for its establishment. Since KRPL is a newly formed entity, the question of acquisition and its completion does not arise.

The creation of KRPL fits with the strategic priorities of Purvah Green Power to support its pursuit of renewable energy opportunities in various of its business lines and to advance the company's overall strategies for all things related to renewables.

About CESC Limited

CESC Ltd., a company in the RP-Sanjiv Goenka Group, was established as the 1st private utility in the country to be involved in power generation, transmission, and distribution, and continues to operate generating electricity for distribution to key markets in West Bengal (Kolkata, Hooghly, Howrah, North and South 24 Parganas)—approximately 3.4 million customers for residential, industrial, and commercial markets. The company is responsible for the execution and management of power generation facilities through subsidiaries in other regions within India while also being responsible for distribution operations in those regions.