Gopaldas Visram AND Company Limited

Gopaldas Visram & Company Limited (GVCL) is a prominent Indian pharmaceutical exporter specializing in the development and manufacturing of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. Established in 1945, the company has over 70 years of experience in the pharmaceutical and cosmeceutical sectors. GVCL operates from its headquarters located at Persian Apartment, Plot No-434, Ground Floor V P Road, Andheri West, Mumbai, Maharashtra 400058. The company is registered under the Corporate Identification Number (CIN) U52100MH2005PLC156917. As of the latest available data, GVCL has an authorized share capital of ₹15.00 crore and a paid-up capital of ₹9.99 crore. The company employs approximately 259 professionals. GVCL's official website is gopaldasvisram.com.

GVCL boasts a manufacturing area exceeding 220,000 square feet, equipped with state-of-the-art Quality Assurance (QA) and Quality Control (QC) laboratories. The company's manufacturing facilities are WHO-GMP certified, ISO 9001:2015 certified, and US FDA approved, ensuring adherence to international quality standards. GVCL's manufacturing capabilities encompass the production of liquids, ointments, powders, granules, and dusting powders, catering to a diverse range of pharmaceutical and cosmeceutical products.

GVCL's leadership team comprises experienced professionals dedicated to the company's growth and operational excellence. Mr. Dinesh Vallabhdas Thakker serves as the Managing Director, overseeing the comprehensive affairs of the group, including sales and marketing. Mr. Mukund Vallabhdas Thakker manages the operational activities of the company, bringing expertise in manufacturing and project management. Mr. Chandresh Vallabhdas Thakker, a commerce and law graduate from Mumbai University, oversees the company's legal and financial affairs. Other key executives include Mr. Chinubhai Shantilal Shah, Mr. Mukesh Chandrakant Khagram, Mr. Jay Mukund Thakker, and Ms. Rita Rajesh Kamani, who contribute to the strategic direction and management of GVCL.

GVCL has established a presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company's manufacturing facilities are US FDA approved, indicating compliance with stringent US regulatory standards. GVCL's products are WHO-GMP certified, ISO 9001:2015 certified, and US FDA approved, facilitating market access in these regions. The company's adherence to international quality standards enhances its credibility and acceptance in these regulated markets.

GVCL has expanded its reach into emerging markets, including Africa, Latin America, and Southeast Asia. The company's WHO-GMP certification and adherence to international quality standards enable it to meet the regulatory requirements of these regions. GVCL's focus on quality and compliance positions it favorably to penetrate and establish a strong presence in these emerging markets.

GVCL's export portfolio is concentrated, with its top two products—Zinc and Hydrocortisone—accounting for 100% of its export value. This concentration indicates a focused product strategy, which may expose the company to risks associated with market fluctuations in these specific products. Diversifying its product range could mitigate such risks and enhance GVCL's resilience in the global market.

GVCL's manufacturing facility is registered with the US FDA, indicating compliance with US regulatory standards. The facility has undergone FDA inspections, with known issues observed during these inspections. The FDA is responsible for inspecting drug manufacturing facilities for violations of good manufacturing practices, such as a lack of documented drug quality testing or contaminated equipment. GVCL's facility has been subject to FDA inspections, and issues have been observed during these inspections.

GVCL's manufacturing facilities are WHO-GMP certified, ensuring adherence to international quality standards. The company also holds ISO 9001:2015 certification, reflecting its commitment to quality management systems. However, there is no specific information available regarding EU GMP certification or EDQM status.

GVCL holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority in India. The company has obtained necessary approvals from state drug controllers and export No Objection Certificates (NOCs), facilitating its export operations. GVCL's compliance with Indian regulatory requirements underscores its commitment to quality and safety in pharmaceutical manufacturing.

GVCL's manufacturing facility has been inspected by the US FDA, with known issues observed during these inspections. The FDA is responsible for inspecting drug manufacturing facilities for violations of good manufacturing practices, such as a lack of documented drug quality testing or contaminated equipment. GVCL's facility has been subject to FDA inspections, and issues have been observed during these inspections.

GVCL operates in a competitive landscape, with several companies offering similar pharmaceutical formulations. While specific market share data is not available, GVCL's focus on quality and compliance with international standards positions it favorably in the market. The company's WHO-GMP certification, ISO 9001:2015 certification, and US FDA approval enhance its credibility and competitiveness.

GVCL's key differentiators include its extensive experience of over 70 years in the pharmaceutical and cosmeceutical sectors, a manufacturing area exceeding 220,000 square feet, and adherence to international quality standards such as WHO-GMP and ISO 9001:2015 certifications. The company's US FDA approval further underscores its commitment to quality and regulatory compliance.

GVCL's current strategic direction focuses on the development and manufacturing of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company's adherence to international quality standards and regulatory approvals positions it well in the global market. Future strategic initiatives may include diversifying its product portfolio and expanding its presence in emerging markets to mitigate concentration risks and enhance growth opportunities.

GVCL has a track record of over 70 years in the pharmaceutical and cosmeceutical sectors, indicating reliability and experience. The company's manufacturing facilities are WHO-GMP certified, ISO 9001:2015 certified, and US FDA approved, reflecting its commitment to quality and compliance. However, known issues have been observed during FDA inspections, which may impact the company's reliability.

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

• FDA Registration: Confirm the facility's registration status with the US FDA.

• WHO-GMP Certification: Verify the facility's certification status with the World Health Organization's Good Manufacturing Practices.

• EU GMP Certification: Check for certification with the European Union's Good Manufacturing Practices.

• ISO 9001:2015 Certification: Ensure the facility holds ISO 9001:2015 certification for quality management systems.

Each certification can typically be verified through the issuing organization's official website or by contacting the organization directly.

Importers should undertake the following verification steps:

• Facility Inspection Reports: Review recent inspection reports from regulatory bodies such as the FDA.

• Certification Validity: Confirm the validity and scope of certifications like WHO-GMP, EU GMP, and ISO 9001:2015.

• Regulatory Compliance History: Assess the company's history of compliance with regulatory requirements.

Red flags to watch for include unresolved regulatory issues, expired certifications, and a history of non-compliance. Recommended pre-order checks involve verifying the authenticity of certifications and assessing the company's reputation in the industry.