Aspiro Pharma Limited

Aspiro Pharma Limited, established in 2012, is a rapidly growing Indian pharmaceutical company specializing in the research, development, and manufacturing of generic parenteral formulations. The company is headquartered in Hyderabad, Telangana, India, with its corporate office located at Plot No.23, Survey No.321, Biotech Park Phase-III, Karkapatla Village, Siddipet District – 502281.

Aspiro Pharma Limited is a public unlisted company, incorporated on 5 February 2014, with a Corporate Identification Number (CIN) of U24100TG2014PLC092771. The company is classified as a non-government company limited by shares. As of the latest available data, Aspiro Pharma Limited has an authorized capital of ₹415 crore and a paid-up capital of ₹404.15 crore.

The company employs between 1,001 and 5,000 individuals, reflecting its significant presence in the pharmaceutical manufacturing sector. Aspiro Pharma Limited's official website is www.aspiropharma.com, providing comprehensive information about its products, services, and corporate updates.

Aspiro Pharma Limited operates a state-of-the-art manufacturing facility located at Plot No.23, Survey No.321, Biotech Park Phase-III, Karkapatla Village, Siddipet District – 502281, Telangana, India. The facility specializes in the production of generic parenteral formulations, including injectables, ophthalmics, pre-filled syringes (PFS), and IV bags. These products are designed to treat a wide range of ailments, demonstrating the company's commitment to addressing diverse therapeutic needs.

As of the latest available information, Aspiro Pharma Limited's leadership includes:

• Bandi Vamsikrishna: Director
• Parthasaradhi Reddy Bandi: Director
• Gopala Krishna Rampalli: Director
• Khadgapathi Podile: Director
• Buchiram Venkat Sobhanadri Suri: Director
• Krishnaveni Kura: Director

These individuals bring a wealth of experience and expertise to the company's strategic direction and operations.

Aspiro Pharma Limited has made significant strides in obtaining regulatory approvals for its products in various international markets. The company's manufacturing facility has received Good Manufacturing Practice (GMP) certifications from several regulatory bodies, including:

• Ukraine Medicines and Drug Control: GMP Certificate
• ANVISA Brazil: GMP Certificate
• UAE Ministry of Health: GMP Certificate
• INVIMA Colombia: GMP Certificate

These certifications underscore Aspiro Pharma Limited's commitment to maintaining high-quality manufacturing standards and its readiness to meet the stringent requirements of regulated markets.

Aspiro Pharma Limited has strategically positioned itself to penetrate emerging markets, including regions in Africa, Latin America, and Southeast Asia. The company's adherence to international quality standards, as evidenced by its GMP certifications from various regulatory bodies, facilitates its entry into these markets. By leveraging these certifications, Aspiro Pharma Limited aims to expand its global footprint and provide access to high-quality medicines in underserved regions.

Aspiro Pharma Limited's geographic strategy focuses on diversification to mitigate concentration risk. The company's export portfolio spans multiple therapeutic categories, including antibiotics, advanced antifungals, and analgesics & antipyretics. This diversification strategy enables Aspiro Pharma Limited to cater to a broad spectrum of therapeutic needs and reduces dependency on a single market segment. The company's expansion into emerging markets further demonstrates its commitment to strategic growth and global presence.

As of the latest available information, Aspiro Pharma Limited has not publicly disclosed specific details regarding its FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, or inspection history. This lack of publicly available information may be due to the company's focus on other international markets or the proprietary nature of such data. For the most accurate and up-to-date information, it is recommended to consult the FDA's official database or contact Aspiro Pharma Limited directly.

Aspiro Pharma Limited's manufacturing facility has received GMP certifications from several international regulatory bodies, including the Ukraine Medicines and Drug Control, ANVISA Brazil, UAE Ministry of Health, and INVIMA Colombia. These certifications attest to the company's adherence to international quality standards. However, as of the latest available information, there is no public record of Aspiro Pharma Limited obtaining WHO prequalification or EU GMP certificates. For the most current information, it is advisable to consult the official websites of the World Health Organization and the European Directorate for the Quality of Medicines & HealthCare.

Aspiro Pharma Limited operates under the regulatory framework of the Central Drugs Standard Control Organisation (CDSCO) in India. The company's manufacturing facility is located in Telangana, India, and is subject to the regulations and oversight of the CDSCO. Specific details regarding CDSCO manufacturing licenses, state drug controller approvals, or export No Objection Certificates (NOCs) are not publicly disclosed. For precise information, it is recommended to consult the CDSCO's official records or contact Aspiro Pharma Limited directly.

As of the latest available information, there are no publicly disclosed records of Form 483 observations, warning letters, or import alerts issued to Aspiro Pharma Limited. This absence of public records suggests that the company maintains a strong compliance record with regulatory authorities. For the most current and detailed information, it is advisable to consult the official websites of the relevant regulatory bodies or contact Aspiro Pharma Limited directly.

Aspiro Pharma Limited operates in a competitive landscape, with several key players in the generic parenteral formulations market. While specific market share data is not publicly available, the company's focus on high-quality manufacturing, as evidenced by its GMP certifications from multiple international regulatory bodies, positions it favorably in the market. Additionally, Aspiro Pharma Limited's strategic expansion into emerging markets demonstrates its commitment to growth and competitiveness.

Aspiro Pharma Limited's key differentiators include its dedicated focus on generic parenteral formulations, a diverse product portfolio spanning multiple therapeutic categories, and adherence to international quality standards as demonstrated by its GMP certifications. The company's strategic expansion into emerging markets further enhances its competitive edge, enabling it to provide high-quality medicines to a broader global audience.

Aspiro Pharma Limited's current strategic direction emphasizes the development and manufacturing of generic parenteral formulations, with a focus on injectables, ophthalmics, pre-filled syringes (PFS), and IV bags. The company's adherence to international quality standards and its expansion into emerging markets reflect a strategic vision aimed at global growth and accessibility. Looking ahead, Aspiro Pharma Limited is well-positioned to leverage its strengths in R&D, manufacturing, and regulatory compliance to achieve sustained success in the pharmaceutical industry.

Aspiro Pharma Limited has demonstrated a strong track record in manufacturing and exporting generic parenteral formulations. The company's export portfolio includes products across multiple therapeutic categories, with a total export value of $8.0 million USD and 234 shipments. The top three products exported are Vancomycin ($5.4 million, 5.8% market share), Voriconazole ($1.4 million, 4.5% market share), and Ketorolac ($1.2 million, 1.0% market share). This diverse product range and consistent export activity indicate a reliable and capable supplier.

Importers should verify the following certifications when considering Aspiro Pharma Limited as a supplier:

• FDA Facility Registration: Confirm the company's registration status with the U.S. Food and Drug Administration.
• WHO-GMP Certification: Verify the company's adherence to World Health Organization Good Manufacturing Practice standards.
• EU GMP Certification: Ensure the company complies with European Union Good Manufacturing Practice standards.
• ISO Certifications: Check for relevant International Organization for Standardization certifications that attest to the company's quality management