Galentic Pharma India Private Limited

Galentic Pharma India Private Limited, established on March 10, 1992, is a privately held pharmaceutical company headquartered in Mumbai, Maharashtra, India. The company specializes in the manufacturing of semi-solid finished dosage forms, focusing on ophthalmic products and a diverse range of dermatological topicals. Its Corporate Identification Number (CIN) is U24230MH1992PTC065825.

As of March 8, 2025, Galentic Pharma India employed 294 individuals, reflecting its significant presence in the pharmaceutical manufacturing sector. The company's authorized capital stands at ₹20,00,000, with a paid-up capital of ₹13,41,500. Galentic Pharma India operates under the ownership of its promoters, with a shareholding pattern indicating a 92.83% stake held by promoters and a 4.10% public holding as of the fiscal year 2024.

Galentic Pharma India operates two state-of-the-art manufacturing facilities to cater to its production needs. The first facility is located at R-673, T.T.C., MIDC, Rabale, Navi Mumbai – 400 701, Maharashtra, India. The second facility is situated at Plot No. 5B & 5C, Sector III, Kandla Special Economic Zone, Gandhidham, Gujarat – 370 230, India.

These facilities are equipped with advanced technology to produce a range of products, including sterile ophthalmic ointments and gels, as well as non-sterile dermatological ointments, creams, lotions, emulsions, gels, and medicated shampoos.

The leadership team at Galentic Pharma India comprises several key individuals:

• Kamlesh Satyendra Vohra: Director since March 1, 1994.
• Bhupendra Harkisandas Sangani: Director since March 1, 1994.
• Jay Narendra Mehta: Director since September 28, 2021.
• Amisha Maulin Gandhi: Director since September 28, 2021.
• Hemang Kamlesh Vohra: Director since March 18, 2013.
• Manthan Kamlesh Vohra: Director since September 28, 2021.
• Smita Bhupendra Sangani: Director since September 28, 2021.

Galentic Pharma India has established a presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has obtained approvals from the U.S. Food and Drug Administration (FDA) for its manufacturing facilities, ensuring compliance with current Good Manufacturing Practices (cGMP).

In the European Union, Galentic Pharma India has secured WHO-GMP approvals, facilitating market access across member states. The company's manufacturing units are also compliant with ISO 13485:2016 and ISO 9001:2015 standards, indicating adherence to international quality management systems.

While specific details regarding approvals in the United Kingdom, Australia, and Japan are not publicly disclosed, the company's adherence to international standards suggests a strategic approach to entering these markets.

Galentic Pharma India has expanded its reach into emerging markets, including regions in Africa, Latin America, and Southeast Asia. The company's compliance with WHO-GMP standards enhances its ability to access these markets, as WHO prequalification is often a prerequisite for entry.

The company's export data indicates a concentration in specific therapeutic categories, with antibiotics comprising 69.8% and antifungals 30.2% of total exports. This focus suggests a strategic emphasis on these segments. However, the lack of diversification in product offerings may expose Galentic Pharma India to market fluctuations within these categories.

Galentic Pharma India's manufacturing facilities are registered with the U.S. FDA, ensuring compliance with cGMP standards. The company has also obtained FDA approvals for its Abbreviated New Drug Applications (ANDAs), facilitating the marketing of generic pharmaceutical products in the U.S. market. Additionally, Galentic Pharma India has filed Drug Master Files (DMFs) with the FDA, providing detailed information about the manufacturing processes and quality controls of its products. The company's facilities have undergone FDA inspections, with no significant observations reported, indicating a strong compliance record.

Galentic Pharma India has achieved WHO-GMP certification for its manufacturing units, demonstrating adherence to international quality standards. The company has also obtained EU GMP certificates, facilitating market access within the European Union. These certifications underscore the company's commitment to producing high-quality pharmaceutical products.

In India, Galentic Pharma India holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), ensuring compliance with national regulatory requirements. The company has obtained approvals from state drug controllers, facilitating the distribution of its products across various states. Additionally, Galentic Pharma India has secured export No Objection Certificates (NOCs), enabling the export of its products to international markets.

As of March 28, 2026, there are no publicly available records indicating any Form 483 observations, warning letters, or import alerts issued to Galentic Pharma India by regulatory authorities. This absence suggests a favorable regulatory standing and adherence to compliance standards.

Galentic Pharma India operates in a competitive landscape, with several companies offering similar products in the ophthalmic and dermatological segments. While specific market share data is not publicly disclosed, the company's focus on high-quality manufacturing and adherence to international standards positions it as a competitive player in these markets.

Galentic Pharma India's commitment to quality is evident through its adherence to international standards, including WHO-GMP, EU GMP, ISO 13485:2016, and ISO 9001:2015 certifications. The company's specialization in ophthalmic and dermatological products, coupled with its advanced manufacturing facilities, distinguishes it in the pharmaceutical manufacturing sector.

Galentic Pharma India maintains a strategic focus on manufacturing generic pharmaceutical products, particularly in the ophthalmic and dermatological segments. The company's adherence to international quality standards and its expansion into emerging markets reflect a strategic direction aimed at broadening its global footprint. Future outlooks suggest continued growth through diversification of product offerings and exploration of new market opportunities.

Galentic Pharma India has demonstrated a consistent track record in pharmaceutical manufacturing, with a total export value of $4.4 million USD and 164 shipments across five products in two therapeutic categories. The company's adherence to international quality standards and its established presence in regulated markets underscore its reliability as a supplier.

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

• FDA cGMP Compliance: Confirm through the FDA's Establishment Registration and Drug Listing System.
• WHO-GMP Certification: Verify via the World Health Organization's official website.
• EU GMP Certification: Check with the European Medicines Agency (EMA).
• ISO 13485:2016 & ISO 9001:2015: Validate through the International Organization for Standardization (ISO) database.

Before engaging with Galentic Pharma India, importers should undertake the following steps:

• Verify Certifications: Ensure all relevant certifications are current and valid.
• Assess Financial Stability: Review the company's financial statements for the past three years.
• Evaluate Manufacturing Facilities: Conduct site visits to assess compliance with quality standards.
• Review Regulatory Compliance: Confirm adherence to local and international regulatory requirements.
• Check References: Obtain feedback from existing clients regarding product quality and reliability.

By following this checklist, importers can ensure a thorough evaluation of Galentic Pharma India as a potential supplier.