Pharmaceutical manufacturer Wanbury Ltd has announced a major regulatory milestone that enhances its credibility and export capabilities. The company secured Good Manufacturing Practices (GMP) certification from Brazil’s National Health Surveillance Agency (ANVISA) for its Raigad-based facility in Maharashtra, specifically for the manufacturing of the Active Pharmaceutical Ingredient (API) – Metformin Hydrochloride.

What the ANVISA GMP Certification Means

The ANVISA GMP certification is a vital regulatory benchmark for pharmaceutical companies aiming to export medicines to Brazil. In Wanbury’s case, this certification affirms that its production processes at the Patalganga Industrial Area in Raigad align with Brazil’s stringent manufacturing norms, which are also in line with World Health Organization (WHO) standards.

This certificate, valid until May 12, 2027, is subject to revocation if Wanbury fails to maintain current GMP practices. Therefore, this achievement not only reflects the company’s current compliance but also places an obligation on continued adherence to international standards.

Focus on Metformin Hydrochloride Production

The certification is specific to the API “Metformin Hydrochloride”, a widely prescribed drug used to treat type 2 diabetes mellitus. With the increasing global prevalence of diabetes, demand for metformin remains robust. By securing ANVISA approval, Wanbury now gains a competitive edge in the export of this API to regulated markets, especially Brazil and other LATAM nations.

Raigad Facility – A Strategic Location

The certified plant is located at A-15, MIDC Industrial Area, Patalganga, which is part of Raigad district in Maharashtra. This area is a key industrial hub, especially for chemical and pharmaceutical companies. The location ensures efficient logistics, access to industrial utilities, and proximity to Mumbai port, supporting faster international dispatches.

Continued Global Certification Efforts: Tanuku Site and EDQM CEP

This is not the first international approval Wanbury has received. Earlier this month, on May 12, the company had informed exchanges about ANVISA’s approval for its Tanuku site in Andhra Pradesh, indicating a pan-India compliance strategy.

Additionally, in September 2024, Wanbury secured a Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines (EDQM) for its Dextromethorphan API. Dextromethorphan is an antitussive commonly used in cough suppressant medications, and a CEP simplifies regulatory approvals across all 27 EU member states.

These multiple certifications demonstrate Wanbury’s commitment to regulatory excellence and its ambitions of expanding to highly regulated international markets.

Financial Performance Snapshot – Q4 FY25

While the regulatory wins are encouraging, Wanbury’s latest quarterly financial results present a mixed picture. For the quarter ended March 31, 2025 (Q4 FY25), the company reported a total income of ₹173.84 crore, reflecting a growth from ₹140.33 crore during the same period last year.

However, net profit declined to ₹20.25 crore, compared to ₹33.63 crore in the previous year’s corresponding quarter. This indicates that while top-line growth has been strong, bottom-line pressures possibly due to cost increases, R&D, or regulatory expenses have impacted profitability.

Stock Market Reaction

As of 12 PM on May 20, Wanbury shares were trading 3.82% lower at ₹292.62 apiece. Despite the day’s dip, the stock has shown strong momentum, having gained 37% over the past six months. This reflects investor optimism around its regulatory achievements and long-term export potential.

Importance of Regulatory Certifications in Pharma Exports

In today’s pharmaceutical landscape, regulatory certifications like ANVISA, EDQM, and USFDA play a pivotal role in shaping a company’s global footprint. These approvals:

• Open up new export markets

• Boost customer confidence in product quality

• Allow participation in high-value tenders and government contracts

• Enable partnerships with international pharma majors

By achieving the ANVISA certification for two of its sites within a span of weeks, Wanbury has positioned itself strongly in this context.

Why Brazil Matters for Indian Pharma

Brazil is among the largest pharmaceutical markets in Latin America and depends heavily on imported APIs for its domestic drug manufacturing. For Indian companies, ANVISA approval is a gateway to tapping this growing demand.

Moreover, Brazil is known for its rigorous regulatory standards, and certification from ANVISA often serves as a validation for other Latin American and European markets, enhancing a company’s global appeal.

Conclusion: Wanbury’s Path Forward

With regulatory approvals coming in from both Brazil and Europe, Wanbury appears to be executing a strategic plan to scale its international business. These certifications also support its efforts to:

• Expand API exports

• Forge global alliances

• Improve manufacturing standards and operational efficiencies

However, the drop in quarterly net profits also points to margin pressures, likely stemming from investments in compliance and capacity expansion. The next few quarters will be crucial in understanding how these certifications translate into revenue growth and profitability.

As India continues to establish itself as the pharmacy of the world, players like Wanbury that prioritize quality compliance and global integration are well-poised to thrive.

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