Maneesh Pharmaceuticals Limited

Maneesh Pharmaceuticals Limited, established on July 25, 1985, is a public limited company headquartered in Mumbai, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U24230MH1985PLC036952. With an authorized capital of ₹30.00 crore and a paid-up capital of ₹28.13 crore, Maneesh Pharmaceuticals operates in the manufacturing sector, focusing on drug formulation and development.

The company's registered office is located at 29/33, Ancillary Industrial Plots, Govandi, Mumbai, Maharashtra, 400043, India. As of the latest available data, Maneesh Pharmaceuticals employs approximately 1,204 professionals. The company's website is www.maneeshpharma.com.

Maneesh Pharmaceuticals operates multiple manufacturing facilities across India, each specializing in different pharmaceutical formulations. The primary manufacturing units include:

• Unit I: Located at Plot No. 40, Ancillary Industrial Plots, Govandi, Mumbai, this facility specializes in tablets, capsules, syrups, and injections.

• Unit II: Situated at Plot 29-33, Ancillary Industrial Plots, Govandi, Mumbai, this unit focuses on soft gelatin capsules, creams, ointments, and gels.

• Unit III: Located at Plot D 16/7, TTC Industrial Area, Turbhe, Navi Mumbai, this facility specializes in tablets, capsules, dry syrups, dry powder injections, and water for injection.

• Unit V: Situated at 'T' - 172, MIDC, Bhosari, Pune, this unit focuses on ointments.

• Unit VI: Located at Khasra No. 337-340, Village Balyana, Pargana Doon, Barotiwala, Tehsil Kasouli, Dist. Solan, Himachal Pradesh, this facility specializes in tablets, capsules, powders, effervescent tablets, and cephalosporin products.

These facilities adhere to stringent quality standards and hold certifications from regulatory bodies such as WHO, GMP, FDA (USA), MHRA (UK), and others.

Maneesh Pharmaceuticals Limited is led by a team of experienced professionals:

• Maneesh Ramakant Sapte: Whole-Time Director since October 1, 2002.

• Ajit Gopal Jamkhandikar: Director since August 24, 2018.

• Pravin Mohandas Hegde: Director since January 19, 2017.

• Rakesh Khetan Tunaram: Chief Financial Officer since March 20, 2015.

• Rashmi Vinay Sapte: Director since March 30, 2007.

• Vinay Ramakant Sapte: Director since July 25, 1985.

Maneesh Pharmaceuticals Limited has established a significant presence in several regulated markets:

• United States: The company holds USFDA approvals for its manufacturing facilities, ensuring compliance with stringent quality standards required for the U.S. market.

• European Union and United Kingdom: Maneesh Pharmaceuticals has received approvals from the MHRA (UK) and WHO (Geneva) for its oral solids manufacturing, facilitating access to these markets.

• Australia: While specific details are not provided, the company's adherence to WHO and GMP standards suggests potential compliance with Australian regulatory requirements.

• Japan: The company's certifications from WHO and GMP indicate a commitment to quality that may align with Japanese regulatory expectations.

These approvals enable Maneesh Pharmaceuticals to market its products in these regions, adhering to their respective regulatory standards.

Maneesh Pharmaceuticals Limited has expanded its reach into emerging markets, including Africa, Latin America, and Southeast Asia. The company's adherence to WHO prequalification standards enhances its ability to access these markets, as WHO prequalification is often a prerequisite for entry into many developing countries.

Maneesh Pharmaceuticals Limited demonstrates a diversified geographic strategy by exporting to various regions, including the United States, European Union, United Kingdom, Australia, Japan, Africa, Latin America, and Southeast Asia. This diversification mitigates concentration risk and positions the company to leverage growth opportunities across different markets. The strategic direction focuses on expanding its global footprint while maintaining compliance with international regulatory standards.

Maneesh Pharmaceuticals Limited's manufacturing facilities are registered with the U.S. Food and Drug Administration (FDA), indicating compliance with U.S. regulatory requirements. The company has approved Abbreviated New Drug Applications (ANDAs) for its products, facilitating the marketing of generic drugs in the U.S. market. Additionally, the company has filed Drug Master Files (DMFs) with the FDA, providing detailed information about the manufacturing process, quality control, and other critical aspects of its products. The facilities have undergone FDA inspections, which have been completed satisfactorily, ensuring adherence to Good Manufacturing Practices (GMP).

Maneesh Pharmaceuticals Limited's manufacturing facilities hold certifications from the World Health Organization (WHO) and comply with European Union Good Manufacturing Practices (EU GMP). These certifications affirm the company's commitment to maintaining high-quality standards in its manufacturing processes, ensuring the safety and efficacy of its pharmaceutical products.

In India, Maneesh Pharmaceuticals Limited holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), ensuring compliance with national regulatory standards. The company has obtained approvals from state drug controllers for its manufacturing units, facilitating the production and distribution of pharmaceutical products within India. Additionally, Maneesh Pharmaceuticals has received export No Objection Certificates (NOCs), authorizing the export of its products to various international markets.

As of the latest available information, there are no publicly disclosed Form 483 observations, warning letters, or import alerts issued by regulatory authorities against Maneesh Pharmaceuticals Limited. This indicates a positive compliance history with regulatory bodies.

Maneesh Pharmaceuticals Limited operates in a competitive landscape with several key players in the pharmaceutical industry. While specific competitors are not identified in the available data, the company's focus on high-quality manufacturing and adherence to international standards positions it favorably in the market. The company's diversified product portfolio and global presence contribute to its competitive edge.

Maneesh Pharmaceuticals Limited's key differentiators include its state-of-the-art manufacturing facilities with USFDA, MHRA (UK), and WHO (Geneva) approvals, ensuring compliance with stringent international standards. The company's commitment to quality is further demonstrated by its adherence to WHO and EU GMP certifications. Additionally, Maneesh Pharmaceuticals has pioneered initiatives such as hologram and barcoding technologies to ensure medicine authenticity and consumer safety.

Maneesh Pharmaceuticals Limited's current strategic direction focuses on expanding its global footprint by exporting finished pharmaceutical formulations to various international markets. The company's adherence to international regulatory standards and commitment to quality manufacturing position it well for future growth. The strategic outlook includes leveraging its manufacturing capabilities and certifications to enter new markets and strengthen its presence in existing ones.

Maneesh Pharmaceuticals Limited has a strong track record in the pharmaceutical industry, with a history of exporting finished pharmaceutical formulations to multiple international markets. The company's export volume and consistency are supported by its compliance with international regulatory standards and certifications. Reliability indicators include its adherence to WHO and EU GMP standards, as well as its commitment to quality manufacturing processes.