Aurochem Pharmaceuticals (india) Privatelimited

Aurochem Pharmaceuticals (India) Private Limited, established on November 21, 1994, is a privately held pharmaceutical company headquartered in Mumbai, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U24230MH1994PTC083100. As of the latest available data, Aurochem Pharmaceuticals has an authorized share capital of ₹2,500,000 and a paid-up capital of ₹1,526,000. The company employs between 11 to 50 individuals, reflecting its mid-sized operational scale. Aurochem Pharmaceuticals specializes in the manufacturing and export of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections, primarily focusing on nutritional supplements and advanced antibiotics.

Aurochem Pharmaceuticals operates manufacturing facilities in Mumbai and Palghar, Maharashtra. The Mumbai facility is located at 334, 3rd Floor, Gundecha Industrial Complex, Akurli Road, Kandivali East, Mumbai, Maharashtra 400101. The Palghar facility is situated at 58, Boisar - Palghar Road, Palghar West, Palghar Taluka Industrial Co-operative Estate, Palghar, Maharashtra 401404. Both facilities are WHO-GMP certified, ensuring compliance with international manufacturing standards. These plants are equipped to produce a range of pharmaceutical products, with a particular emphasis on nutritional supplements and advanced antibiotics.

The leadership team at Aurochem Pharmaceuticals comprises several key individuals:

• Pravinchandra Bhikhabhai Desai: Director since November 21, 1994.

• Piyush Mansukhlal Shah: Director since November 21, 1994.

• Pallav Mahesh Shah: Director since April 1, 2015.

• Himanshu Pravin Desai: Director since February 8, 2014.

These individuals have been instrumental in steering the company's strategic direction and operational growth.

Aurochem Pharmaceuticals has established a presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company's manufacturing facilities hold WHO-GMP certifications, which are recognized by regulatory authorities in these regions. This certification facilitates the export of their pharmaceutical products to these markets. While specific regulatory filings and approvals in each country are not detailed in the available sources, the WHO-GMP certification indicates a commitment to maintaining high manufacturing standards, aligning with the requirements of these regulated markets.

Aurochem Pharmaceuticals has expanded its reach into emerging markets, including regions in Africa, Latin America, and Southeast Asia. The WHO-GMP certification of their manufacturing facilities enables the company to access these markets, as it is a prerequisite for many countries in these regions to import pharmaceutical products. This strategic move allows Aurochem Pharmaceuticals to tap into growing healthcare needs and establish a broader global footprint.

Aurochem Pharmaceuticals demonstrates a diversified geographic strategy by exporting its products to various international markets, including the United States, European Union, United Kingdom, Australia, Japan, and emerging markets in Africa, Latin America, and Southeast Asia. This approach mitigates concentration risk and leverages opportunities across different regions. The company's WHO-GMP certification supports its ability to enter and compete in these diverse markets, reflecting a strategic direction focused on global expansion and market diversification.

Specific details regarding Aurochem Pharmaceuticals' FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly available in the provided sources. However, the company's WHO-GMP certification suggests adherence to international manufacturing standards, which is a critical factor for FDA approval processes. To obtain precise information on FDA-related approvals and inspections, direct communication with the company or the FDA would be necessary.

Aurochem Pharmaceuticals' manufacturing facilities are WHO-GMP certified, indicating compliance with the World Health Organization's Good Manufacturing Practices. This certification is recognized by the European Union and is essential for exporting pharmaceutical products to EU member countries. The WHO-GMP certification underscores the company's commitment to maintaining high manufacturing standards, ensuring product quality and safety in international markets.

Aurochem Pharmaceuticals holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority in India. The company's facilities are also approved by state drug controllers, ensuring compliance with Indian pharmaceutical manufacturing regulations. Additionally, the WHO-GMP certification of their manufacturing facilities facilitates the issuance of export No Objection Certificates (NOCs), enabling the company to export pharmaceutical products to various international markets.

There are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Aurochem Pharmaceuticals. The absence of such records suggests that the company maintains a strong compliance record with regulatory authorities. However, for the most current and detailed information, it is advisable to consult the official websites of the relevant regulatory bodies or contact Aurochem Pharmaceuticals directly.

Aurochem Pharmaceuticals operates in a competitive landscape with several key players in the pharmaceutical manufacturing sector. While specific competitors in overlapping categories are not detailed in the available sources, the company's focus on nutritional supplements and advanced antibiotics positions it in markets with significant competition. The WHO-GMP certification and the company's export activities indicate a competitive edge in meeting international standards and accessing global markets.

Aurochem Pharmaceuticals' key differentiators include its WHO-GMP certified manufacturing facilities, which ensure adherence to international quality standards. The company's focus on finished pharmaceutical formulations, particularly in the areas of nutritional supplements and advanced antibiotics, allows it to cater to specific market needs. Additionally, the company's strategic expansion into emerging markets demonstrates its adaptability and commitment to global growth.

Aurochem Pharmaceuticals' current strategic direction emphasizes the production and export of finished pharmaceutical formulations, with a particular focus on nutritional supplements and advanced antibiotics. The company's WHO-GMP certification supports its ability to meet international manufacturing standards, facilitating access to regulated markets. Looking ahead, Aurochem Pharmaceuticals may consider expanding its product portfolio to include generics, specialty drugs, biosimilars, or contract development and manufacturing organization (CDMO) services to further enhance its market position and growth prospects.

Aurochem Pharmaceuticals has demonstrated a consistent track record in exporting pharmaceutical products, with a total export value of $715,000 USD across 46 shipments from 2022 to 2026. The company's portfolio is concentrated, with its top three products—Chondroitin, Glucosamine, and Ornidazole—accounting for 100% of its exports. This concentration indicates a focused product strategy, which can be advantageous in maintaining quality and expertise in specific therapeutic areas. The WHO-GMP certification of its manufacturing facilities further underscores the company's commitment to quality and reliability in its export operations.

Importers should verify the following certifications when considering Aurochem Pharmaceuticals as a supplier:

• WHO-GMP Certification: This certification ensures that the manufacturing facilities adhere to the World Health Organization's Good Manufacturing Practices, indicating compliance with international quality standards.

• EU GMP Certification: This certification confirms that the manufacturing processes meet the European Union's Good Manufacturing Practices, which is essential for exporting pharmaceutical products to EU member countries.

• FDA Registration: While specific FDA facility registrations are not detailed in the available sources, importers should verify the company's registration status with the U.S. Food and Drug Administration to ensure compliance with U.S. regulations.

• ISO Certifications: These certifications indicate adherence to international standards for quality management systems, which can be crucial for ensuring product consistency and reliability.

To verify these certifications, importers can request copies of the certificates directly from Aurochem Pharmaceuticals or consult the official websites of the respective certifying bodies.