Anzalp Pharmasolutions is the commercial face of a diversified Indian healthcare group — generics, oncology, critical care, nutraceuticals, contract development and molecular diagnostics, supplied to 45 countries.
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.
Alongside the contract and private-label work, we develop and own a small number of consumer brands — including a patented gel-matrix delivery platform used across both topical and systemic ranges.
Systemic gel-matrix supplements — copper, iron, zinc, manganese, creatine, glutamine and fructose jellies. Vegan, gluten-free, sugar-free.
Topical water-soluble gel range built on the same patented matrix.
Sexual wellness range — preservative-free, Ecocert and Cosmos certified, pH optimised.
Quadrivalent influenza vaccine brands.
Chlorine-dioxide disinfection and virus-prevention range.
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 across 45 countries.
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.
The forty-five countries on the map at the top of this page each hold their own view of what a dossier must contain, what stability data must prove and in what order the approvals must be obtained.
This chapter is why the 45 countries figure means something. 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.
ANVISA CBPF and GCC-DR accreditation 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.
Anzalp Pharmasolutions Pvt. Ltd. is the commercial face of a diversified Indian healthcare group, operating across generics, oncology, critical care, nutraceuticals, contract development and molecular diagnostics.
The parent company was established in the 1960s and passed through six decades of reiterations, mergers, de-mergers and vertical differentiation. Anzalp Pharmasolutions, incorporated in 1991, is the current expression of that business.
We do not 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, rather than a new entrant.
The distinction matters to anyone conducting diligence, so we set it out rather than blur it.
Facilities operated by Anzalp and within the group, covering the dosage forms that make up the bulk of our commercial portfolio. Batch records, quality systems and site approvals sit with us directly.
Partner facilities selected, audited and worked through for categories requiring dedicated plant — biologics, inhalation devices, high-potency and cytotoxic handling, transdermal systems and segregated beta-lactam suites. Anzalp remains the contracting and accountable party.
Manufacturing plants built for other pharmaceutical companies in India and abroad, IV fluid and large-volume parenteral facilities, hospitals, and research centres specified to biosafety level through our engineering network.
Anzalp is privately held and does not publish ownership or board composition, in keeping with standard practice for companies of our structure. What we publish is who is accountable for what this site claims.
Signs on behalf of Anzalp for every distribution, licensing and manufacturing contract we enter.
The named signatory on our quality agreements, and the contact for site audits, quality documentation and COPP requests — in-house or across the network.
Owns dossier strategy across CTD, ACTD and ANDA/505(b)(2) filings, and is the contact for registration status by market.
Quality, regulatory affairs, formulation development and commercial operations are run in-house, by the people named above and the teams they lead. Manufacturing scale — plasma fractionation, biologics, vaccines, and the hospitals and biosafety-level facilities we have engineered — is delivered through our qualified network: audited, contracted and accountable to us, not headcount we carry ourselves.
The Shri Hari Charitable Trust was founded by the patriarchs of the group Anzalp belongs to, and Anzalp and its people continue to support its work — providing free education to underprivileged girls across rural India. Over more than twenty years the Trust has educated 8,000+ girls across 20+ villages — many now doctors, engineers, accountants and entrepreneurs, and some have returned to teach in the schools that educated them.
Distribution, 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.
Partners typically arrive for one and expand into others without re-qualifying a new supplier. The quality systems, documentation standards and supply discipline are shared across all of them.
Over four hundred formulations across oral solids, sterile injectables, capsules, dry syrups and rehydration salts.
Oncology is the clearest measure of whether a manufacturer has the systems it claims to have: contained handling, cytotoxic segregation, lyophilisation and cold chain, on molecules with narrow margins for error.
Neuromuscular blockers, sedatives, analgesics and reversal agents in ampoule and vial presentations.
Supplied for private-label and white-label partnership, or under a partner's own brand. Composition and presentation are agreed against the destination market.
Manufactured under FSSAI Central Licence as a Manufacturer-Exporter of food and health supplements, with laboratory testing at minimum once every six months per product line.
We work backwards from the molecule and the destination market — selecting the dosage form, defining the regulatory route, identifying the facility and preparing the dossier the destination regulator will accept.
DNA testing that helps patients and clinicians confirm genetic variations affecting drug metabolic rates, identify rare genetic disorders, clarify biological relationships and support identity confirmation.
We work on the principle of personalised medicine — that important DNA variations should inform the treatment plan chosen for each individual patient. Tailored treatment based on molecular genetic test results is now a practical possibility rather than a research proposition.
Distribution, 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.
Twelve categories covering every major pharmaceutical dosage form and the development services around them. Each item is marked according to whether it runs in-house or through our qualified manufacturing network.
No pharmaceutical company manufactures every one of these forms within its own walls. We describe our capability as what it is — part owned, part networked — which is also why we are able to tell a partner, before commitment, which facility would run their product and what its regulatory standing is.
Distribution, 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.
Rather than present a wall of logos, we set out what each credential is, who issues it and which market it opens. The specific site and its standing are confirmed when a product and destination market are on the table.
| Credential | Issued by | What it means and which market it opens |
|---|---|---|
| WHO-GMP + COPP | CDSCO, following joint inspection with the State Licensing Authority | The baseline export credential. The Certificate of Pharmaceutical Product is product-specific and valid two years. Most importing regulators across Africa, CIS, Latin America, South-East Asia and the Middle East will not open a registration file without it. Applications are filed through the ONDLS portal. |
| Revised Schedule M | CDSCO / State Licensing Authority | India's restructured statutory GMP framework across twelve subparts, bringing Indian GMP substantially closer to WHO and EU expectations. It is an Indian requirement rather than a WHO or EU credential. |
| EU GMP | A named national competent authority — never EMA | Published on EudraGMDP and accepted across the EU and EEA. The issuing authority is always named; a bare "EU-GMP approved" claim is unverifiable. |
| US FDA | US FDA (CDER) | Facility registration and cGMP inspection against 21 CFR 210/211. The FDA inspects and classifies; it does not issue GMP certificates, so the correct description is "US FDA-inspected facility". |
| ANVISA CBPF | ANVISA, Brazil | Granted after on-site inspection and required before product registration is issued — a gating credential for the largest Latin American market. |
| GCC-DR accreditation | Gulf Central Committee for Drug Registration | Site accreditation followed by product registration from a single harmonised dossier across the Gulf states, together with eligibility for group purchasing tenders. |
| NPRA Malaysia | National Pharmaceutical Regulatory Agency | Foreign GMP inspection with submissions via QUEST3+ in ACTD format — a dossier that also travels across ASEAN. |
| WHO Prequalification | WHO Department of Regulation and Prequalification | Distinct from WHO-GMP. Dossier assessment with published site inspection and sample testing, unlocking UN and donor-funded procurement. |
| PIC/S alignment | Not a company credential — PIC/S admits regulators | India's CDSCO is not a PIC/S participating authority. The accurate descriptions are "operated in compliance with PIC/S GMP guidelines" or "GMP certificate issued by a PIC/S member authority". |
| Format | What it is |
|---|---|
| CTD / eCTD | The ICH-harmonised five-module dossier and its electronic implementation. Mandatory for US FDA and EMA submissions. |
| ACTD | The ASEAN Common Technical Dossier — four parts, no Module 2. The format for Malaysia and across ASEAN. |
| ANDA §505(j) | US generic application demonstrating bioequivalence to a Reference Listed Drug. |
| NDA §505(b)(2) | Hybrid US application relying partly on data the applicant does not own — the route for new strengths, routes, combinations or reformulations. |
| DMF / ASMF / CEP | Confidential API filings: US Type II DMF, the EU Active Substance Master File, and the EDQM Certificate of Suitability. |
| Country registration pack | COPP, free sale certificate, GMP certificate, manufacturing licence, certificate of analysis, specifications, method validation, stability data, bioequivalence where required, local-language artwork and power of attorney. |
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 establishing that at registration stage costs a year.
Zone assignments vary between references; shown indicatively.
Distribution, 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.
Whichever route applies, the first conversation is the same: what is the molecule, what is the market, and what does registration there actually require.
You hold the market and the registration route; we supply the product and the dossier support behind it. Suited to partners adding depth across a therapeutic area rather than listing single products.
What we need: target markets, therapeutic priorities, registration status and expected volumes.
You hold the brand and the market; we develop, manufacture and document the product, from formulation and dossier preparation through to commercial supply.
What we need: the molecule, target dosage form, market and regulatory standard required.
Selective out-licensing of proprietary assets to partners with the regulatory and commercial reach to commercialise them. Discussions proceed under confidentiality agreement before asset-specific detail is shared.
What we need: therapeutic focus, territories held and the stage at which you typically in-license.
Requesting the appropriate level shortens the process considerably. This is what each contains and what is required to release it.
| Level | Released | What it contains |
|---|---|---|
| Capability statement | On request | Company profile, divisions, dosage-form and technology coverage, therapeutic segments, market footprint, quality frameworks and contact routes. |
| Product portfolio | On request | Product list by therapeutic segment with molecule, strength, dosage form and pack presentation, filtered to your market. |
| Product dossier | Under CDA — request via quality@anzalp.com | Quality data in CTD or ACTD format, certificate of analysis, stability data by climatic zone, analytical method validation, Site Master File, GMP certificate and COPP. Released against a signed confidentiality agreement and a defined market. |
ANVISA CBPF and GCC-DR accreditation must exist before a product file is opened. Reversing this order costs a full cycle.
CTD for regulated markets, ACTD for ASEAN via QUEST3+. Determined by the destination rather than by convenience.
Zone IVb long-term data where the market requires it, generated on the batches that will be registered.
Where required — and for endogenous hormones, with baseline correction designed in from the outset.
COPP, free sale certificate, GMP certificate, certificate of analysis, method validation and local-language artwork.
If a molecule requires a facility standard we cannot reach, a registration route that does not work in your market, or a timeline the chemistry will not support, we will say so in the first conversation.
Distribution, 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.
Enquiries relating to distribution, contract manufacturing and licensing are all handled through the partnering inbox.
An enquiry form should sit here in the live build, routed to the partnering inbox and capturing molecule, market, dosage form and volume — so that the first reply can be substantive rather than a request for further information.
Distribution, 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.