Medley Pharmaceuticals Limited Pharmaceutical Export Profile — India (DGFT 2022–2026)

Name: Medley Pharmaceuticals Limited Pharmaceutical Export Portfolio Dataset — 4 Products, $5.5M FOB USD, India (DGFT 2022–2026)
Creator: TransData Nexus

Suresh Sormare

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Medley Pharmaceuticals Limited — Pharmaceutical Exporter Profile (2026) | 4 Products, $5.5M Trade | TransData Nexus

Medley Pharmaceuticals Limited

Indian Pharmaceutical Exporter · Antifungals Specialist · $5.5M Total Trade · DGFT Verified

Medley Pharmaceuticals Limited is an Indian pharmaceutical exporter with a total trade value of $5.5M across 4 products in 4 therapeutic categories. Based on 219 verified export shipments from Indian Customs (DGFT) records, the company actively competes across multiple product segments. Top exports include Nystatin ($3.5M), Clarithromycin ($1.1M), Pioglitazone ($616.1K).

Medley Pharmaceuticals Limited — Export Portfolio & Destination Treemap

Medley Pharmaceuticals Limited pharmaceutical export portfolio — 4 products across 4 therapeutic categories. Source: Indian Customs (DGFT).

Who is Medley Pharmaceuticals Limited? — Company Overview & Market Position

Medley Pharmaceuticals Limited, established in 1969, is a Mumbai-based pharmaceutical company specializing in the manufacturing and marketing of finished pharmaceutical formulations. The company is registered under the Corporate Identification Number (CIN) U24230MH1975PLC018296. Medley operates as a public unlisted company, with an authorized capital of ₹33 crore and a paid-up capital of ₹30.06 crore. Employing over 3,000 individuals, approximately 2,200 of whom are part of the sales force, Medley ranks among the top 40 pharmaceutical companies in India, according to ORG IMS. The company's website is www.medleylab.com.

What Does Medley Pharmaceuticals Limited Export? — Product Portfolio Analysis

Top Products by Export Value

1Nystatin$3.5M 2Clarithromycin$1.1M

Product Portfolio — Top 4 by Export Value

Medley Pharmaceuticals Limited exports 4 pharmaceutical products across 4 therapeutic categories.

#	Product	Category	Export Value	Shipments	Market Share	Rank
1	Nystatin	Antifungals	$3.5M	69	6.6%	4
2	Clarithromycin	Antibiotics	$1.1M	22	1.1%	11
3	Pioglitazone	Diabetes & Endocrine	$616.1K	78	1.7%	11
4	Domperidone	Gastrointestinal	$372.3K	50	1.3%	12

Medley Pharmaceuticals Limited exports 4 pharmaceutical products across 4 therapeutic categories with a total export value of $5.5M. The top category is Antifungals (62.3% of portfolio), followed by Antibiotics (19.9%), indicating a concentrated portfolio with the top 5 products accounting for 100.0% of total export value.

Medley Pharmaceuticals Limited — Corporate Profile & Information

Headquarters, ownership, manufacturing facilities, and key leadership

1Corporate Overview

2Manufacturing Facilities

Medley Pharmaceuticals operates multiple manufacturing facilities across India. In 1976, the company established a formulation plant in Aurangabad, followed by units in Daman and Jammu. These facilities adhere to Good Manufacturing Practices (GMP), ensuring high-quality standards at every stage of the manufacturing process. Additionally, Medley has a state-of-the-art Active Pharmaceutical Ingredient (API) manufacturing facility located in Tarapur, Maharashtra, which is equipped with a dedicated R&D center to facilitate seamless process transfer from laboratory to plant.

3Key Leadership

Medley Pharmaceuticals is led by a team of experienced professionals. The company's leadership includes individuals such as Sahir Sami Khatib, Suhel Sami Khatib, and Mirasif Mirmohsin Ali, who serve as directors. While specific titles such as CEO, MD, and CFO are not explicitly mentioned in the available sources, the company's leadership structure comprises these key individuals.

TransData Nexus Research · Government registries, company filings, regulatory databasesMar 2026

Where Does Medley Pharmaceuticals Limited Export? — Destination Intelligence

Regulated market presence, emerging market penetration, and geographic strategy

1Regulated Markets

Medley Pharmaceuticals has made significant strides in entering regulated markets. The company has obtained approvals from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its facility, indicating compliance with stringent quality standards. Medley is also in the process of obtaining approvals from the Medicines Control Council (MCC) of South Africa and the National Health Surveillance Agency (ANVISA) of Brazil, demonstrating its commitment to expanding its presence in regulated markets. The company is on the verge of entering the U.S. market after obtaining the necessary approvals from U.S. authorities.

2Emerging Markets

Medley Pharmaceuticals has expanded its reach to emerging markets, including regions in Africa, Latin America, Southeast Asia, and Europe. The company's products are marketed in 24 countries across these regions, reflecting its global footprint. While specific details regarding WHO prequalification are not available, Medley's extensive distribution network and international presence suggest a strategic focus on emerging markets.

3Geographic Strategy

Medley Pharmaceuticals Limited — Manufacturing & Regulatory Profile

FDA status, WHO-GMP certification, EU GMP compliance, and regulatory track record

1FDA Status

Specific details regarding Medley Pharmaceuticals' FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not available in the provided sources. However, the company's efforts to enter the U.S. market, as indicated by obtaining approvals from U.S. authorities, suggest ongoing engagement with the FDA.

2WHO & EU GMP

Medley Pharmaceuticals has obtained approvals from the UK's Medicines and Healthcare products Regulatory Agency (MHRA), indicating compliance with EU Good Manufacturing Practices (GMP). While specific details regarding WHO prequalification are not available, the company's adherence to international quality standards suggests a commitment to meeting global regulatory requirements.

3CDSCO & Indian Regulatory

Medley Pharmaceuticals holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), ensuring compliance with Indian regulatory standards. The company's facilities in Aurangabad, Daman, and Jammu are operational, adhering to Good Manufacturing Practices (GMP). Specific details regarding state drug controller approvals and export No Objection Certificates (NOCs) are not available in the provided sources.

Medley Pharmaceuticals Limited — Competitive Positioning Among Indian Pharma Exporters

Market share comparison, key differentiators, and strategic analysis

1Competitive Landscape

Medley Pharmaceuticals operates in a competitive landscape with several key players in the pharmaceutical industry. While specific market share comparisons are not available, the company's diverse product portfolio, including specialties in Hematinics, Anti-ulcerants, Anti-bacterials, Pain management, Gynecology, and cardiovascular drugs, positions it to compete effectively across multiple therapeutic segments.

2Key Differentiators

Medley Pharmaceuticals differentiates itself through its extensive product portfolio, including unique offerings such as R.B. Tone Syrup, Dompan (Domperidone & Pantoprazole), O2 (Ornidazole & Ofloxacin), Tazocef (Tazobactam & Ceftriaxone), and Ostium K2 (the first brand of Vitamin K2 combination in India). The company's commitment to quality, as evidenced by its adherence to Good Manufacturing Practices (GMP) and international regulatory approvals, further strengthens its competitive position.

3Strategic Position

Medley Pharmaceuticals' current strategic direction focuses on expanding its global footprint by entering regulated markets and emerging regions. The company's efforts to obtain approvals from the UK's MHRA, the MCC of South Africa, and ANVISA of Brazil, as well as its impending entry into the U.S. market, reflect a strategic emphasis on international growth. Looking ahead, Medley is likely to continue leveraging its diverse product portfolio and manufacturing capabilities to strengthen its position in both domestic and international markets.

Buyer Due Diligence Brief — Evaluating Medley Pharmaceuticals Limited as a Supplier

Track record assessment, certifications to verify, and pre-order checks

1Supplier Assessment

Medley Pharmaceuticals has demonstrated a consistent track record in manufacturing and exporting pharmaceutical formulations. The company's total export value of $5.5 million USD across 219 shipments, with products spanning four therapeutic categories, indicates a stable export volume. The top five exported products—Nystatin, Clarithromycin, Pioglitazone, and Domperidone—account for 100% of the company's export portfolio, highlighting a focused product strategy. The company's adherence to Good Manufacturing Practices (GMP) and international regulatory approvals further underscores its reliability as a supplier.

2Certifications to Verify

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

FDA Facility Registration: Confirm the company's registration status with the U.S. Food and Drug Administration (FDA) to ensure compliance with U.S. regulations.

WHO-GMP Certification: Verify adherence to World Health Organization's Good Manufacturing Practices to ensure product quality and safety.

Frequently Asked Questions — Medley Pharmaceuticals Limited

How many pharmaceutical products does Medley Pharmaceuticals Limited export from India?

Medley Pharmaceuticals Limited exports 4 pharmaceutical products across 4 therapeutic categories. The top exports are Nystatin ($3.5M), Clarithromycin ($1.1M), Pioglitazone ($616.1K), Domperidone ($372.3K). Total export value is $5.5M.

What is Medley Pharmaceuticals Limited's total pharmaceutical export value?

Medley Pharmaceuticals Limited's total pharmaceutical export value is $5.5M, based on 219 verified shipments recorded in Indian Customs (DGFT) data.

What therapeutic categories does Medley Pharmaceuticals Limited cover?

Medley Pharmaceuticals Limited exports across 4 therapeutic categories. The largest are Antifungals (62.3%, 1 products), Antibiotics (19.9%, 1 products), Diabetes & Endocrine (11.1%, 1 products).

Get Full Medley Pharmaceuticals Limited Export Intelligence

Access shipment-level details, pricing data, buyer connections, product breakdown, and competitive analysis. TransData Nexus provides verified Indian Customs (DGFT) data trusted by pharmaceutical trade professionals worldwide.

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Official References & Regulatory Resources

Verify manufacturer licensing, GMP certification, and export registration with the agencies above.

Research Methodology & Data Transparency

Suresh Sormare

Verified Author

Pharmaceutical Export-Import Analyst & Trade Intelligence Expert

Suresh Sormare is a pharmaceutical export-import analyst with deep expertise in Indian Customs (DGFT) data, HS code classification, and global pharmaceutical supply chains. His analysis covers 10M+ shipment records across 150+ countries and is used by manufacturers, procurement agencies, and trade consultants worldwide. Suresh specializes in identifying verified suppliers and buyers from customs records, mapping bilateral pharmaceutical trade corridors, analyzing tariff structures and regulatory frameworks across 170+ destination markets, and benchmarking competitive positioning for finished pharmaceutical formulations. His methodology combines granular customs transaction data with regulatory intelligence from FDA, EMA, WHO, CDSCO, and 40+ national drug authorities to deliver actionable trade insights for the pharmaceutical formulations sector.

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Primary Data Source

All trade data is sourced from Indian Customs (DGFT) official shipping bill records — the authoritative government database for India's pharmaceutical trade. Each verified record contains exporter name, consignee (buyer) name, detailed product description, quantity, declared FOB value (USD), port of loading, destination country, and shipment date.

Data Source & Methodology

Trade data sourced from Indian Customs (DGFT) export shipment records. Values represent FOB export value in USD. Market share calculated relative to total Indian pharmaceutical exports per product category. For current shipment-level data, contact TransData Nexus.