Beta Drugs a Himachal Pradesh based pharma company has achieved a major regulatory milestone — COFEPRIS (Mexico regulatory authority for drugs) approval for its oncology formulation plant in Baddi and API (Active Pharmaceutical Ingredient) unit under Adley Lab in Derabassi, Punjab. Notably, ace investor Ashish Kacholia holds 12,63,826 shares (12.5% stake in the company), worth INR 223.7 crore.
A Gateway to Latin America’s Second Largest Oncology Market
This is not just regulatory housekeeping — it’s a strategic play. Mexico’s oncology formulation market is valued at around USD 1.3 billion (~INR 10,960 crore) and is the second largest in Latin America after Brazil. Beta Drugs has already laid the groundwork by submitting 22 finished formulation dossiers and 10 Drug Master Files (DMFs) as part of its aggressive Latin American expansion plan.
Global Compliance is a Signature of Quality
COFEPRIS approval adds to Beta’s growing list of international certifications after ANVISA (Brazil) and EAEU. These approvals reflect Beta Drugs’ focus on GMP compliance, end-to-end quality control and regulatory alignment with key international markets — the holy trinity of pharma supply chain.
As part of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), Mexico’s approval now gives a multiplier effect: Beta’s API and formulation facilities are now eligible for registration across other PIC/S member countries and can access dozens of new regulated markets without redundant inspections.
Adley Labs
The inclusion of Adley Labs in the COFEPRIS approval is significant. By getting approval for its API facility, Beta Drugs has achieved what many mid-sized pharma companies struggle with — supply chain sovereignty. Vertical integration through in-house API production ensures quality consistency and cost efficiency and operational margins — a big advantage as raw material costs fluctuate globally.
EU Audit in Pipeline
Beta Drugs has filed for EU audit for its Baddi formulation plant by December 2025. If this happens, it will add another feather to its cap in regulated, high barrier to entry markets — a big plus in oncology space.
Beta Drugs Post-IPO Performance
Beta Drugs launched its INR 19.52 crore IPO on 4 October 2017. The IPO was a totally fresh issue which subscribed 17.8x. Beta Drugs listed with 19.94% returns on listing day. the stock reached its all-time high of INR 2,093.43 per share on 6 December 2024. it is the magnificent ~4,000% returns from its 5 years low of INR 43.33 per share.
Future Ready
The global oncology market is in an expansion phase driven by increasing cancer prevalence, innovation in targeted therapies and increasing healthcare investments in emerging economies. Beta Drugs with its forward integrated model and growing list of international certifications is well positioned to capture demand in domestic and international markets.
As a stock market analyst this series of regulatory approvals tells a great story — Beta Drugs is shifting gears from a domestic formulation player to a global oncology export company. The story is clear — this is not just about regulatory wins; it’s about strategic thinking, execution discipline and global ambition.