SRI Krishna Pharmaceuticals Limited

Established on September 26, 1974, Sri Krishna Pharmaceuticals Limited (SKPL) is a prominent Indian pharmaceutical company headquartered in Hyderabad, Telangana. The company operates as a public limited entity, classified as a non-government company limited by shares, with a Corporate Identification Number (CIN) of U24230TG1974PLC001790. SKPL specializes in the bulk manufacture of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and finished dosage forms, including tablets, capsules, syrups, and injections.

As of the latest available data, the company has an authorized capital of ₹150 million and a paid-up capital of ₹119.185 million. While specific revenue figures are not publicly disclosed, SKPL has a workforce ranging from 501 to 1,000 employees, reflecting its substantial operational scale. The company's official website, www.srikrishnapharma.com, provides comprehensive information about its products, services, and regulatory certifications.

SKPL operates multiple manufacturing facilities across Telangana and Maharashtra, each dedicated to specific product lines to ensure specialized production. These facilities are equipped with modern equipment and adhere to stringent Good Manufacturing Practice (GMP) standards. Notably, the company's Unit I has been inspected and approved by the US FDA, Therapeutic Goods Administration (TGA) of Australia, and the World Health Organization (WHO) for the production of Acetaminophen (Paracetamol) and Domperidone. Additionally, Unit II has received GMP compliance certificates from German, Brazilian (ANVISA), and Mexican (COFEPRIS) regulatory authorities.

As of the latest available information, the key managerial personnel at Sri Krishna Pharmaceuticals Limited include:

• Nikhil Bihari Pandey: Chief Financial Officer (CFO)
• Kalluru Manaswini: Company Secretary

These executives play pivotal roles in steering the company's strategic direction and ensuring compliance with regulatory standards.

Sri Krishna Pharmaceuticals Limited has established a significant presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company's manufacturing facilities have undergone inspections and received approvals from various regulatory bodies:

• United States: The US FDA has approved SKPL's facilities for the production of Acetaminophen (Paracetamol) and Domperidone.

• European Union: The European Directorate for the Quality of Medicines & HealthCare (EDQM) has granted Certificates of Suitability (CEP) for products such as Acetaminophen, Domperidone, and Folic Acid.

• Australia: The Therapeutic Goods Administration (TGA) has recognized SKPL's facilities for compliance with GMP standards.

• United Kingdom: The Medicines and Healthcare products Regulatory Agency (MHRA) has approved SKPL's facilities for the production of various pharmaceutical products.

• Japan: Specific regulatory approvals from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) are not detailed in the available sources.

These approvals underscore SKPL's commitment to maintaining high-quality standards and its capability to meet the stringent requirements of these markets.

Sri Krishna Pharmaceuticals Limited has expanded its reach into emerging markets across Africa, Latin America, and Southeast Asia. The company's adherence to international quality standards, as evidenced by certifications from the World Health Organization (WHO), facilitates its entry into these regions. By obtaining WHO prequalification, SKPL enhances its credibility and access to these markets, enabling it to supply essential medicines to underserved populations.

SKPL's geographic strategy demonstrates a balanced approach to market diversification. While the company has a strong presence in regulated markets such as the US, EU, UK, Australia, and Japan, it has also made strategic inroads into emerging markets in Africa, Latin America, and Southeast Asia. This diversification mitigates concentration risk and positions SKPL to capitalize on growth opportunities across different regions. The company's commitment to quality and regulatory compliance supports its strategic direction, allowing it to navigate diverse market landscapes effectively.

Sri Krishna Pharmaceuticals Limited's facilities have been inspected and approved by the US Food and Drug Administration (FDA) for the production of Acetaminophen (Paracetamol) and Domperidone. The company holds multiple Drug Master Files (DMFs) for various products, including Glipizide, Phenylephrine, Meclizine, and Doxylamine Succinate. These approvals and filings reflect SKPL's adherence to FDA standards and its capability to supply products to the US market.

SKPL's commitment to quality is demonstrated through its certifications from the World Health Organization (WHO) and the European Directorate for the Quality of Medicines & HealthCare (EDQM). The company has obtained Certificates of Suitability (CEP) from EDQM for products such as Acetaminophen, Domperidone, and Folic Acid. These certifications affirm SKPL's compliance with international quality standards, enhancing its reputation in global markets.

In India, Sri Krishna Pharmaceuticals Limited operates under the regulatory oversight of the Central Drugs Standard Control Organisation (CDSCO). The company's manufacturing facilities are licensed by the CDSCO, ensuring compliance with national standards. Additionally, SKPL has obtained export No Objection Certificates (NOCs) from the Directorate General of Foreign Trade (DGFT), facilitating its international trade activities.

As of the latest available information, there are no publicly disclosed Form 483 observations, warning letters, or import alerts issued by the US FDA or other regulatory bodies against Sri Krishna Pharmaceuticals Limited. This absence of recent regulatory actions indicates the company's ongoing commitment to maintaining high-quality standards and regulatory compliance.

In the global pharmaceutical industry, Sri Krishna Pharmaceuticals Limited faces competition from both domestic and international manufacturers. Key competitors include companies such as Aurobindo Pharma, Dr. Reddy's Laboratories, and Sun Pharmaceutical Industries, which also offer a range of APIs and finished dosage forms. While specific market share data is not available, SKPL's focus on quality, regulatory compliance, and a diversified product portfolio positions it as a competitive player in the industry.

Sri Krishna Pharmaceuticals Limited distinguishes itself through its vertical integration, encompassing the production of APIs, PFIs, and finished dosage forms. This integration allows for greater control over the manufacturing process and product quality. The company's commitment to quality is further evidenced by its certifications from various regulatory bodies, including the US FDA, WHO, and EDQM. Additionally, SKPL's expansion into nutraceuticals reflects its adaptability and responsiveness to market trends.

Sri Krishna Pharmaceuticals Limited's current strategic direction focuses on maintaining operational excellence in its existing drug portfolio while developing innovative new products. The company's expansion into nutraceuticals indicates a forward-looking approach to diversifying its offerings. Looking ahead, SKPL aims to enhance its research and development capabilities and explore new market opportunities to sustain growth and competitiveness.

Sri Krishna Pharmaceuticals Limited has demonstrated a consistent track record in manufacturing and exporting pharmaceutical products. The company's export volume and consistency are supported by its regulatory certifications and approvals from various international bodies. Indicators of reliability include adherence to GMP standards, successful inspections by regulatory authorities, and a diversified product portfolio catering to multiple therapeutic categories.

Importers should verify the following certifications to ensure product quality and regulatory compliance:

• FDA: Confirm facility registrations and approved Drug Master Files (DMFs) through the FDA's official database.

• WHO-GMP: Obtain certification details from