A little about Emcure Pharmaceuticals. The lack of much export to more developed countries gives me a bit of concern about quality, as does the regulatory problems at that specific factory they produce the medicine at. I wish there were an easy, cost-effective way to have the medicine evaluated:
The following profile details the size, financial standing, and quality reputation of Emcure Pharmaceuticals Ltd. as of late 2025.
Quick Snapshot
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Industry Rank: 13th Largest in India (Domestic Sales)
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Market Cap: ~₹27,000 Cr ($3.2B USD)
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Primary Focus: Gynecology (#1 in India), HIV Antivirals, Cardiac, and Biologics.
1. Ranking & Financial Magnitude
Emcure is a significant Tier-1 player in the Indian pharmaceutical market (IPM), distinct for its heavy reliance on the domestic market compared to its export-heavy peers.
| Metric |
Value / Rank |
Context |
| India Rank |
13th |
Based on domestic sales (MAT FY24). It is the 4th largest company in its specific “covered markets” (therapeutic areas it competes in). |
| Revenue (FY24) |
₹6,658 Cr (~$800M) |
Domestic sales contribute approx. 48% of total revenue, which is higher than many Indian pharma peers who rely more on US exports. |
| Revenue (TTM) |
₹8,449 Cr (~$1B) |
Trailing 12-Months as of Sept 2025. Growth has accelerated recently, driven by new product launches. |
| Market Cap |
~₹27,000 Cr |
Listed on NSE/BSE in July 2024. Currently valued as a mid-cap pharma stock. |
| Key Segments |
#1 in Gynecology |
Also holds leadership positions in HIV (Antivirals) and Iron supplements. |
Note on Growth: Emcure has outperformed the Indian Pharmaceutical Market (IPM) growth rate in domestic sales over the last 3 years (CAGR of ~10% vs industry ~8%).
2. Quality Reputation & Regulatory Status
Emcure’s reputation is currently in a “Recovery and Redemption” phase. Historically plagued by severe regulatory issues, the company has made significant strides in 2024–2025 to clear its compliance record.
The “Red Flag” History (2015–2019)
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Warning Letters: The company suffered severe reputational damage due to US FDA warning letters in 2016 and 2019 for its Hinjewadi (Pune) facility.
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Issues Cited: Regulators cited data integrity breaches, poor aseptic processing techniques, and failure to investigate batch discrepancies. This effectively locked them out of significant US export opportunities for years.
Current Status: Significant Improvement (2024–2025)
As of December 2025, the company has successfully cleared multiple critical inspections, signaling a turnaround in manufacturing quality.
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Gujarat (Kadu) Facility: Received “No Action Indicated” (NAI) status from the US FDA in December 2025 (Inspection Oct 2025). This is the highest compliance rating, meaning no objectionable conditions were found—a major “clean chit.”
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Sanand (Oncology) Facility: Concluded a US FDA Pre-Approval Inspection in July 2025 with Zero Observations.
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Pune (API) Facility: Received 2 Observations (Form 483) in Feb 2025. However, this was later classified as VAI (Voluntary Action Indicated) in April 2025, meaning the FDA accepted their corrective plan and the facility is compliant enough to continue operations/exports.
Summary Verdict
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Commercial Strength: High. They are a dominant domestic force with a unique “brand-building” model rather than just generic commodities. They own the gynecological niche in India.
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Quality Risk: Moderate (Improving). While the historical data integrity issues were severe, the “Zero Observation” and “NAI” results in late 2025 suggest they have overhauled their quality management systems. They are no longer in the “danger zone” they were in 5 years ago.
Emcure manufactures Axentri (Maraviroc) at its primary solid oral dosage facility in Pune, Maharashtra .
Based on the product packaging and regulatory filings, the specific factory details are:
Manufacturing Location
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City: Pune, Maharashtra
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Facility Zone: Hinjewadi (a major IT and Biotech park in Pune)
- Specific Address:
Emcure Pharmaceuticals Ltd. Survey No. 255/2, Phase-I, Hinjewadi, Pune - 411 057, Maharashtra, India.
Facility Context
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Role: The Hinjewadi plant is Emcure’s headquarters and flagship facility. It is responsible for manufacturing the majority of their HIV antiretrovirals (ARVs) and solid oral formulations (tablets/capsules) for both the Indian domestic market and export to emerging markets.
Based on the manufacturing location of Axentri (Maraviroc) at the Hinjewadi, Pune facility, here is the specific quality and regulatory status for that site.
Facility Snapshot: Hinjewadi Phase-1 (Pune)
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Role: Emcure’s Headquarters & Flagship Facility (Solid Orals & Injectables).
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US FDA Status: Restricted / Official Action Indicated (OAI)
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Last Major Regulatory Action: Warning Letter (August 2019)
Detailed Quality Reports & Inspection History
Unlike Emcure’s newer facilities in Gujarat (which recently received a “clean” status), the Hinjewadi facility has a troubled regulatory history with the US FDA that has not yet been fully publicly resolved “close-out” as of late 2025.
1. The “Import Alert” (Ban) Status
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Status: The facility is under Import Alert 66-40.
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Meaning: This effectively bans most products manufactured at this site from entering the US market. The FDA placed this ban due to violations of “Good Manufacturing Practices” (GMP).
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The “Exception” for HIV Drugs: Crucially, the US FDA often grants exemptions for essential drugs where there is a shortage or medical necessity. Certain antiretrovirals (like Cidofovir and likely Maraviroc/Axentri) have historically been excluded from the ban, allowing them to be exported despite the facility’s overall non-compliant status.
2. Key FDA Observations (The “Red Flags”) The 2019 Warning Letter (which followed a 2015 ban) cited specific quality failures at Hinjewadi that impacted its reputation:
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Data Integrity: The most damaging finding was that data regarding sterility and quality testing was not reliable. The FDA cited instances where test results were potentially manipulated to pass batches that should have failed.
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Sterility Issues: For injectable lines, investigators found poor aseptic techniques (e.g., operators moving too quickly, disrupting sterile airflow) and contaminated media plates.
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Environmental Monitoring: Failure to properly monitor the manufacturing environment for bacteria/contaminants.
Current Verdict on “Axentri” Quality
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For the US Market: The facility is not considered fully compliant with US standards, but Axentri (as an HIV drug) likely falls under a “medical necessity” exemption allowing it to be sold.
Summary: While Emcure as a company has cleaned up its act in 2024–2025 (clearing inspections at its Sanand and Gujarat plants), the Hinjewadi facility where Axentri is made remains the “legacy problem” site with unresolved US FDA warning letters. The quality is sufficient for domestic approval but has historically failed to meet the higher bar of US regulatory clearance.
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