Vivimed Life Sciences Private Limited

Vivimed Life Sciences Private Limited, established on February 20, 2017, is a private limited company incorporated under the Companies Act, 2013, with its registered office at 201, Devavrata, Sector 17, Vashi, Navi Mumbai – 400 703, Maharashtra, India. The company operates in the manufacturing sector, focusing on pharmaceutical formulations, and is classified as a non-government company. Its Corporate Identification Number (CIN) is U24304MH2017PTC348859. Vivimed Life Sciences is a wholly owned subsidiary of Strides Pharma Science Limited, following Strides' acquisition of the remaining 50% stake from Vivimed Labs Limited on January 29, 2019. The company has an authorized share capital of ₹300 million and a paid-up capital of ₹282.67 million. As of the latest available data, Vivimed Life Sciences employs approximately 289 professionals. The company's official website is not specified in the available sources.

Vivimed Life Sciences operates manufacturing facilities in Alathur, Tamil Nadu, and Banjara Hills, Hyderabad, Telangana. The Alathur plant is located at Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram District, Tamil Nadu 603110, India. The Hyderabad facility is situated at 8-2120/86/9/A/1 & 12, Anil Athmaja Housing Society, Road No. 2, Banjara Hills, Hyderabad, Telangana 500034, India. Specific details regarding the manufacturing capacities and specializations of these facilities are not available in the provided sources.

The key leadership team at Vivimed Life Sciences Private Limited includes:

• Vikesh Kumar: Director since February 20, 2019.

• Venkata Seetharama Raju Pakalapati: Director since April 25, 2024.

• Umesh Pralhadrao Kale: Director since February 20, 2019.

The roles of Chief Executive Officer (CEO) and Chief Financial Officer (CFO) are not specified in the available sources.

Vivimed Life Sciences Private Limited has engaged in the U.S. market through its manufacturing facility in Alathur, Tamil Nadu. In May 2019, the company voluntarily recalled 19 lots of Losartan Potassium Tablets USP due to the detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), a potential carcinogen, above the FDA's acceptable exposure limit. This recall indicates the company's compliance with U.S. regulatory standards. Specific information regarding the company's presence in the European Union (EU), United Kingdom (UK), Australia, and Japan, including regulatory filings, approvals, and market access status, is not available in the provided sources.

Vivimed Life Sciences Private Limited has demonstrated a presence in emerging markets, particularly in Africa, Latin America, and Southeast Asia. The company's export data indicates shipments to countries such as Kenya and South Africa, suggesting engagement in the African market. Additionally, the company's manufacturing facilities in Alathur, Tamil Nadu, and Banjara Hills, Hyderabad, Telangana, may facilitate access to Southeast Asian markets. Specific details regarding WHO prequalification or other certifications enabling access to these markets are not available in the provided sources.

Vivimed Life Sciences Private Limited's geographic strategy appears to focus on both domestic and international markets. The company's manufacturing facilities in Alathur, Tamil Nadu, and Banjara Hills, Hyderabad, Telangana, suggest a strong domestic presence. Internationally, the company's export data indicates shipments to various countries, including the United States, Kenya, and South Africa, reflecting a diversified export strategy. However, the company's portfolio concentration, with the top five products accounting for 100% of exports, indicates a potential risk if demand for these products declines. Diversifying the product portfolio could mitigate this risk and enhance the company's strategic position.

Vivimed Life Sciences Private Limited has engaged with the U.S. Food and Drug Administration (FDA) through its manufacturing facility in Alathur, Tamil Nadu. In May 2019, the company voluntarily recalled 19 lots of Losartan Potassium Tablets USP due to the detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), a potential carcinogen, above the FDA's acceptable exposure limit. This recall indicates the company's compliance with FDA regulations. Specific details regarding FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not available in the provided sources.

Specific information regarding WHO prequalification, EU Good Manufacturing Practice (GMP) certificates, and European Directorate for the Quality of Medicines & HealthCare (EDQM) status for Vivimed Life Sciences Private Limited is not available in the provided sources. These certifications are crucial for market access in various regions and for ensuring product quality and safety.

Vivimed Life Sciences Private Limited operates under the regulatory framework of the Central Drugs Standard Control Organisation (CDSCO) in India. The company's manufacturing facilities in Alathur, Tamil Nadu, and Banjara Hills, Hyderabad, Telangana, are subject to CDSCO regulations. Specific details regarding CDSCO manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs) are not available in the provided sources.

In May 2019, Vivimed Life Sciences Private Limited voluntarily recalled 19 lots of Losartan Potassium Tablets USP due to the detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), a potential carcinogen, above the FDA's acceptable exposure limit. This recall indicates the company's proactive approach to regulatory compliance and product safety. No other recent regulatory actions, such as Form 483 observations, warning letters, or import alerts, are available in the provided sources.

Vivimed Life Sciences Private Limited operates in the pharmaceutical industry, focusing on finished pharmaceutical formulations. The company's top competitors in overlapping categories include major pharmaceutical companies that produce analgesics, antibiotics, and antifungals. While specific market share comparisons are not available in the provided sources, Vivimed's export data indicates a diversified export strategy, with shipments to various countries, including the United States, Kenya, and South Africa. This suggests that Vivimed competes with both domestic and international players in these markets.

Vivimed Life Sciences Private Limited's key differentiators include its manufacturing facilities in Alathur, Tamil Nadu, and Banjara Hills, Hyderabad, Telangana, which enable it to serve both domestic and international markets. The company's export data indicates shipments to countries such as the United States, Kenya, and South Africa, reflecting a diversified export strategy. Additionally, the company's proactive approach to regulatory compliance, as demonstrated by the voluntary recall of Losartan Potassium Tablets USP in May 2019, underscores its commitment to product safety and quality.

Vivimed Life Sciences Private Limited's current strategic direction appears to focus on the production of finished pharmaceutical formulations, including analgesics, antibiotics, and antifungals. The company's export data indicates a diversified export strategy, with shipments to various countries, including the United States, Kenya, and South Africa. The company's portfolio concentration, with the top five products accounting for 100% of exports, suggests a need for product diversification to mitigate potential risks. Future outlooks would benefit from expanding the product portfolio and enhancing market presence in emerging markets.

Vivimed Life Sciences Private Limited has demonstrated a consistent track record in its export activities, with 116 shipments recorded between 2022 and 2026, totaling an export value of $5.8 million USD. The company's top three exported products—Ibuprofen, Clindamycin, and Nystatin—account for 100% of its export portfolio, indicating a focused product strategy. The company's export data indicates shipments to various countries, including the United States, Kenya, and South Africa, reflecting a diversified export strategy.