Anzalp Pharmasolutions is the commercial face of a diversified Indian healthcare group — generics, oncology, critical care, nutraceuticals, contract development and molecular diagnostics.
They are set out here because a partner is entitled to understand a supplier's standards before entering into a relationship, rather than discovering them afterwards.
One contract, one quality agreement, one point of accountability — regardless of which facility in the network runs the batch. A partner should never have to work out who is responsible for a deviation.
Our purpose is to put medicines and nutraceuticals within reach of the people who need them — through the skill and discipline of our scientists, analysts and technicians, and through continuous quality improvement pursued in an ethical and empathetic manner.
Documentation, traceability and disclosure that stand up to a regulator's question and a partner's audit. We would rather decline a request early than fail it late.
Reducing consumption of natural resources and contribution to greenhouse gas emissions by modernising chemical processes and equipment — preserving the environment while improving the lives of our consumers.
Partners typically arrive for one and expand into others — without re-qualifying a new supplier each time. The quality systems, documentation standards and supply discipline are shared across all of them.
Oral solids, sterile injectables, dry syrups and ORS across the anti-infective, analgesic, gastro, respiratory and cardio-metabolic segments.
Tablets, capsules, liquid injections and lyophilised vials — targeted therapies, classical cytotoxics, hormonal oncology and supportive care.
Neuromuscular blockers, sedatives, analgesics and reversal agents in ampoule and vial presentations.
Tablets, capsules, powders, syrups and infant nutritional formulas under FSSAI Central Licence, offered private-label or white-label.
Formulation, analytical method and dossier development through to commercial supply, for partners who hold the brand and the market.
DNA testing for drug-metabolism variation, rare genetic disorders, biological relationship and identity confirmation.
Anzalp has designed and delivered manufacturing facilities for other pharmaceutical companies — in India and abroad — and has built hospitals. It is an unusual thing for a formulator to be able to say, and it is the reason the network model works: we have specified, commissioned and qualified the kind of plant we now place work into.
Biosafety level is not a label applied to a finished building — it is a set of engineering decisions taken at concept stage about airflow direction, envelope integrity, entry sequence and effluent. Each level below adds requirements to the one before it rather than replacing them.
Containment centres are delivered through our qualified engineering network; scope and level are agreed against the specific programme.
Over four hundred formulations across oral solids, sterile injectables, capsules, dry syrups and rehydration salts — the segments that move volume in every market we supply.
Oncology is the hardest thing a generic manufacturer can attempt: contained handling, cytotoxic segregation, lyophilisation and cold chain, all on molecules with narrow margins for error. It is also the clearest measure of whether a manufacturer has the systems it claims to have.
Manufactured under FSSAI Central Licence as a Manufacturer-Exporter of food and health supplements, with lab testing at minimum once every six months per product line. Offered private-label under a buyer's brand, or custom-formulated within FSSAI parameters.
The group behind Anzalp began manufacturing in the 1960s. Six decades of mergers, de-mergers and vertical build-out later, Anzalp Pharmasolutions — incorporated in 1991 — is where that capability sits today: the formulation library, the manufacturing base, and a distribution network built by some 20,000 colleagues that has carried the group's products to roughly 25 million people.
We don't present that history as an overnight achievement of our own. We present it as continuity — which is why qualifying Anzalp means qualifying six decades of accumulated practice, not a new entrant.
Some of it we make ourselves. The rest runs through manufacturing partners we have qualified and audited — which is how a partner gets one accountable counterparty instead of six suppliers.
If you are the person who has to qualify a supplier, this is the part that matters. Three chapters: how a dose is engineered, how the difficult work is handled, and how a product actually reaches a market.
This chapter sits under Generics and Contract Development — the two businesses that rest on one skill: turning a molecule into a dose that performs the same way in month thirty-six as it did on day one.
A dosage form is a machine. Where the membrane sits, how the layers stack and what the orifice diameter is are the difference between a product that performs and one that fails dissolution at month nine.
The curve is the product. Immediate release empties in an hour; an osmotic pump holds a straight line for twenty; a pulsatile system delivers, waits, then delivers again. Choosing between them is a clinical decision before it is a manufacturing one.
Plasma, hormones and cytotoxics share a property that ordinary formulation does not: a mistake is not a failed batch, it is a contaminated one. Each demands containment, segregation or process control designed in from concept stage.
This chapter sits under Oncology & Cytotoxic, Human Plasma Products and Hormones — and behind the engineering capability, because the containment described here is what we have built for other companies.
Plasma is the least forgiving material in the industry: one pool, many products, and every step constrained by the one after it. Understanding where each protein separates is the difference between a supply relationship and a guessing game.
Supply into the EU requires a Plasma Master File certified by the EMA, with human plasma for fractionation controlled to Ph. Eur. 0853. Pathogen safety is assessed on the orthogonality of the inactivation steps, never on any single one.
Hormone suites face a design conflict: negative pressure protects the operator, positive pressure protects the product. The resolution is an airlock bubble either side — and it is the first thing a competent auditor asks to see.
The exposure limit sets the maximum permissible airborne concentration; the containment device is then selected and performance-qualified by surrogate powder testing to demonstrate it holds below that figure. Ethinylestradiol is clinically active at 15–35 micrograms a day — which is why hormone residue that would be analytically trivial for a 500 mg antibiotic is a full pharmacological dose.
Revised EU GMP Chapter 3 replaced the categorical list with a risk statement, and Chapter 5.20 requires a quality risk management process including toxicological evaluation. Hormone PDEs are typically low enough that dedication is the outcome of that assessment rather than a rule.
21 CFR 211.42(d) mandates separate facilities for penicillin, and the 2022 draft framework extends comprehensive separation to all beta-lactam classes. For hormones the FDA relies on the general 211.42(c) requirement for "such other control systems as are necessary".
WHO TRS 986 Annex 2 states that hormone production "should not be conducted in the same facilities" as other products. India's Revised Schedule M carries a dedicated Part III for hazardous substances including sex hormones and steroids.
A site qualified against the EU's risk-based test is not automatically acceptable to a WHO-aligned regulator, and the reverse also holds. We establish which rulebook governs your destination market before selecting the facility — because a mismatch discovered at inspection is costly to correct and slow to recover from.
Each export market holds its own view of what a dossier must contain, what stability data must prove and in what order the approvals must be obtained.
Supplying a market is a sequence, and the sequence is unforgiving of the wrong order.
Zone IVb is the practical gatekeeper for ASEAN, Brazil, the Gulf and much of Africa. A dossier built on Zone II data does not travel there, and finding that out at registration stage costs a year.
Zone assignments vary between references; shown indicatively.
The site's approval must exist before a product file is opened. Reversing this costs a full cycle.
CTD for regulated markets, ACTD for ASEAN via QUEST3+. Set by the destination, not by convenience.
Zone IVb long-term data where the market demands it, on the batches that will be registered.
Where required — and for endogenous hormones, with baseline correction designed in from the start.
COPP, free sale certificate, GMP certificate, CoA, method validation, local-language artwork.
Formulation, analytical method and dossier development against your target market — working backwards from where the product has to be registered.
Site selection and audit against the regulatory standard your market actually requires, not the one that is easiest to obtain.
One contract, one quality agreement, one point of accountability — regardless of which facility runs the batch.
We come back with the dosage form, the regulatory route, the facility that should make it and what registration will take. If we are not the right partner, we will say so.
Start a conversationDistribution, contract manufacturing and licensing all reach the same desk. Write to us with the product and the territory, and the first reply will be substantive.