Global Reach
Connecting Capabilities to Global Needs
The parent's commercial mandate is to open and hold markets that its operating companies can then supply. Manufacturing is one part of that chain; the registrations, the local representation and the route to the customer are the parts that decide whether the manufacturing has anywhere to go.
Primary Export Markets
Long-term supply networks.
Our strategic commercial expansion strategies are highly focused on establishing robust, long-term supply networks across key international regions, including:
The CIS Region
Delivering advanced formulations tailored to specific regulatory environments, including the Russian Federation.
Southeast Asia
Expanding distribution and healthcare access points throughout Vietnam and neighboring markets.
West Africa
Securing reliable, high-volume pharmaceutical supply chains across Ghana and Nigeria.
Regulatory pathways
What each market requires.
The CIS Region
Registration across the Eurasian Economic Union runs through a single harmonised procedure covering Armenia, Belarus, Kazakhstan, Kyrgyzstan and the Russian Federation. Since 1 January 2026 that procedure has applied across the union in full, so one accepted dossier carries the product into all five markets.
Amendments in force since June 2025 also widened the GMP basis: an applicant may support the file with a GMP certificate from an EAEU authority or an equivalent from the FDA, EMA or PMDA, undertaking to complete an EAEU inspection within three years of registration.
- Authority
- EAEU unified procedure
- Dossier
- EAEU CTD, Modules 1–5
- GMP basis
- EAEU, or FDA/EMA/PMDA equivalent
- Local presence
- Authorised representative in a member state
- Statutory review
- 210 days, excluding clock stops
Southeast Asia
Vietnam assesses against the ASEAN Common Technical Dossier, so one dossier structure serves the market and, with country-specific annexes, its neighbours. Marketing authorisation is governed by Circular 32/2026/TT-BYT, issued on 29 July 2026 and effective from 1 October 2026, which replaces the circular that had applied since July 2025.
The Certificate of Pharmaceutical Product requirement has eased in successive revisions: a single CPP from the manufacturing country's authority, or from an EMA or stringent regulatory authority, and deferred submission is now permitted in defined cases.
- Authority
- Drug Administration of Vietnam
- Dossier
- ACTD, Parts I–IV
- Governing rule
- Circular 32/2026/TT-BYT
- Local presence
- Representative office required
- Statutory review
- 12 months from submission
West Africa
Ghana's Food and Drugs Authority and Nigeria's NAFDAC both assess in ICH CTD format and both hold WHO Maturity Level 3. NAFDAC reached ML3 in 2022, the first national regulator in Africa to do so for medicines and vaccines, and had that status reaffirmed with effect from 30 June 2025.
Nigeria's documentary chain is heavier than most: the Certificate of Pharmaceutical Product and the GMP certificate must be authenticated by the Nigerian Mission in the country of origin, not merely notarised. Approval follows dossier review, inspection of the production facility and laboratory analysis before the Food and Drug Registration Committee issues the certificate, which runs five years and is renewable.
- Authority
- FDA Ghana · NAFDAC Nigeria
- Dossier
- ICH CTD with WHO CPP
- Maturity level
- WHO ML3, both regulators
- Local presence
- Registered local agent
- Certificate validity
- 5 years, renewable (Nigeria)
Current as at August 2026; indicative, not contractual. Registration requirements and assessment timelines are set by each regulator and revised periodically — Vietnam's governing circular changed in July 2026 and the EAEU transition completed in January 2026. Confirm the current position with the relevant authority or local agent before relying on any detail above.
Why the registration holder matters
Whoever holds the registration holds the market.
In every one of these markets a foreign manufacturer is barred from holding the registration in its own name. It passes to an authorised representative, a local agent, or a locally established entity.
Marketing Authorisation holder
Holding the authorisation keeps the dossier, the brand and the customer relationship inside the group. Where a third-party distributor holds it instead, continued access to that market depends on that relationship continuing.
Local Technical Representative
Acting as the appointed representative in territories that require one — regulatory correspondence, pharmacovigilance obligations and post-marketing commitments handled directly rather than through an intermediary.
Market context
The base we build from.
India supplies roughly one in five generic medicines sold worldwide and ranks third globally in pharmaceutical production by volume.
Export figures from the Pharmaceuticals Export Promotion Council (Pharmexcil), quarter to June 2026. The 2030 target is from Healing the World: Roadmap for Making India a Global Pharma Exports Hub, published by the Indian Pharmaceutical Alliance, IDMA and Pharmexcil in February 2025. Figures describe the Indian industry, not the company.