Export active pharmaceutical ingredients from India with the regulatory dossier your buyer review demands
M Care Exports is a CDSCO-licensed Indian merchant exporter and manufacturer-side partner for formulators and importers sourcing active pharmaceutical ingredients, the bulk drug substances dosed into a finished medicine. We do not manufacture. We place your API requirement with WHO-GMP and ICH Q7 compliant Indian producers, then assemble the US DMF, EU CEP, written confirmation and quality pack a second-source qualification needs. India ships to 49 export markets through our Mumbai desk.
What an API enquiry through M Care covers
An active pharmaceutical ingredient is the bulk drug substance that gives a medicine its effect, supplied to a formulator who turns it into tablets, capsules, injectables or other dosage forms. This page is about that bulk-substance trade, distinct from our finished-dose export work. We match your molecule to a qualified Indian producer and carry the regulatory evidence through to your dossier.
Molecule sourcing and second-source matching
You name the API, target pharmacopoeia and annual volume band. The Mumbai desk shortlists Indian manufacturers holding the right GMP scope, route of synthesis and regulatory filings, then returns named options under a confidentiality agreement. The aim is a qualified second source that de-risks a single-supplier or single-country dependency in your supply chain.
Regulatory dossier reference
We confirm whether the producer holds a US DMF Type II, an EU CEP from the EDQM, or an Active Substance Master File, and arrange the letter of access or reference your filing needs. Where a destination requires it, we coordinate the CDSCO written confirmation under Article 46b for import of the active substance into the EU.
Quality and impurity documentation
Each lot ships with a Certificate of Analysis against the stated USP, Ph. Eur. or IP monograph, plus residual-solvent data to ICH Q3C, elemental-impurity control to ICH Q3D, and a nitrosamine risk assessment where the molecule structure warrants it. Specification, method and stability summaries are assembled for your review.
When buyers come to us for a bulk drug substance
We need to diversify away from a single country
China-plus-one and broader supply diversification are driving formulators to add a qualified Indian source for APIs they currently buy from one origin. India is among the largest API producers globally and supplies a substantial share of the active substances on the WHO prequalified list, which makes it a credible second origin. We place the requirement and carry the qualification evidence.
We are qualifying a second source for a filed product
Adding an alternate API supplier to an approved drug product means matching the route of synthesis, impurity profile and DMF or CEP reference, then running the regulatory variation. We shortlist producers whose filings and specifications align to your existing source so the comparability and change-control work is manageable for your regulatory team.
Is a DMF or CEP available for this molecule
Buyers often need to know, before committing, whether an Indian producer already holds a US DMF Type II or an EU CEP for the exact API and salt form. We confirm the filing status, the holder, and how a letter of access or reference is granted, so your dossier strategy is settled early rather than after a purchase order.
Price pressure on a formulation's COGS
When the active substance is the dominant cost in a finished product, a competitive and compliant Indian source can ease pressure on cost of goods without compromising the dossier. We benchmark landed cost against documented quality so the saving is real and defensible, not a quality trade-off that surfaces at audit.
The documentation pack a formulator or importer asks for
A regulatory affairs or procurement reviewer qualifying a bulk drug substance works from a defined evidence set. The Mumbai desk assembles it from the manufacturer's quality system, current-dated and indexed, under a confidentiality agreement before any commercial commitment.
US DMF Type II reference
Confirmation that the producer holds an active Type II Drug Master File with the US FDA covering the API, intermediate and process, with arrangement of the letter of authorisation your ANDA or NDA review will cite.
EU CEP or ASMF
A Certificate of Suitability issued by the EDQM confirming the active substance complies with its European Pharmacopoeia monograph, or an Active Substance Master File with the open and restricted parts handled correctly for your EU filing.
Written confirmation under Article 46b
For active substances imported into the EU, the written confirmation issued by CDSCO, the competent authority of the exporting country, attesting GMP equivalent to EU standards, as required by the Falsified Medicines Directive 2011/62/EU.
CoA, specs and method
Certificate of Analysis against the agreed USP, Ph. Eur. or IP monograph, the release and shelf-life specification, analytical methods, and the designated regulatory starting material per ICH Q7.
Impurity and nitrosamine data
Residual-solvent control to ICH Q3C, elemental-impurity assessment to ICH Q3D, an organic impurity profile, and a nitrosamine risk assessment with confirmatory testing where the molecule or process indicates a risk.
GMP and stability evidence
The ICH Q7 GMP status of the API site, the relevant manufacturing licence, and stability data supporting the proposed retest or expiry period for the bulk substance as supplied.
From enquiry to supply, step by step.
- Define the API requirement. You provide the molecule, salt or base, target pharmacopoeia, expected annual volume, destination market and whether you need a primary or second source. The desk confirms the regulatory route the destination demands, US DMF, EU CEP plus written confirmation, or another national filing.
- Shortlist qualified producers. We match the requirement to ICH Q7 compliant Indian manufacturers holding the right filings and route of synthesis, then return named options with their DMF or CEP status, pharmacopoeial compliance and capacity, all under a confidentiality agreement before pricing.
- Assemble the qualification pack. The Mumbai desk pulls the CoA, specification, methods, impurity and nitrosamine data, GMP status and DMF or CEP reference from the producer's quality system, indexes it and sends a single current-dated pack to your regulatory and procurement reviewers.
- Arrange references and confirmation. We coordinate the letter of access for the DMF or the CEP reference, and where the active substance is bound for the EU, the CDSCO written confirmation under Article 46b. Sample or qualification-quantity lots are arranged for your incoming testing.
- Supply against the agreed dossier. On qualification, commercial lots ship from the named site against the locked specification, with lot-specific CoA and impurity data each time. Change controls, retest dates and any filing variation are tracked on a buyer-specific timeline through the Mumbai desk.
The specifics.
Does M Care manufacture the API?
No. M Care Exports is an India-based pharmaceutical merchant exporter and the manufacturer-side commercial and regulatory partner for the Indian API producers on our roster. We will not claim to manufacture. The active substance, the DMF or CEP, the written confirmation and the GMP certificate are all issued in the manufacturer's name. Our role is to match your requirement to the right producer and carry the qualification evidence through to your dossier.
What is the difference between an API and your finished-dose export work?
An active pharmaceutical ingredient, or bulk drug substance, is the raw active material a formulator doses into tablets, capsules or injectables. This page covers that bulk-substance trade. Our finished-dose export work supplies the completed, packed medicine ready for a patient or pharmacy. They use different regulatory instruments, a DMF or CEP for the API versus a marketing authorisation and CoPP for the finished product, so we keep the two enquiry paths separate.
Can you confirm a US DMF Type II before we commit?
Yes. Before any purchase order, under a confidentiality agreement, we confirm whether the nominated Indian producer holds an active Type II Drug Master File with the US FDA for the exact API and salt form, who the holder is, and how the letter of authorisation is granted for your ANDA or NDA review. Type II DMFs cover active pharmaceutical ingredients and their intermediates, so this is the standard reference for a US-bound second source.
What is the EU written confirmation and why is it needed?
Under Article 46b of Directive 2001/83/EC, as amended by the Falsified Medicines Directive 2011/62/EU, active substances imported into the EU must be accompanied by a written confirmation from the competent authority of the exporting country. For India that authority is CDSCO. It attests that the API was made to GMP standards equivalent to the EU and that the site is supervised. We coordinate this document from CDSCO for EU-bound shipments where the exporting country is not on the EU equivalence list.
What is a CEP and how does it differ from a DMF?
A Certificate of Suitability, or CEP, is issued by the EDQM and certifies that an active substance complies with its European Pharmacopoeia monograph; it can support EU filings in place of part of an Active Substance Master File. A US Drug Master File is a separate confidential submission to the US FDA. They serve different jurisdictions, so a second source bound for both markets usually needs both a CEP and a US DMF. We confirm which the producer holds.
What is ICH Q7 and the regulatory starting material?
ICH Q7 is the internationally harmonised Good Manufacturing Practice standard for active pharmaceutical ingredients, adopted by the FDA, EMA and other authorities. The regulatory starting material is the point in the synthesis from which full GMP applies, defined in the filing and approved on review. We confirm the producer's ICH Q7 status and that the designated starting material in the dossier matches what your regulatory team expects.
What impurity and nitrosamine data do you provide?
Each lot is supported by residual-solvent control to ICH Q3C, an elemental-impurity assessment to ICH Q3D, and an organic impurity profile against the agreed monograph. Where the molecule structure or the synthetic route presents a nitrosamine risk, a risk assessment and, where indicated, confirmatory testing are provided. This is the impurity evidence a regulatory reviewer expects when qualifying a bulk drug substance.
Why source an API from India for China-plus-one diversification?
India is among the largest API producers globally and supplies a significant share of the active substances on the WHO prequalified list, which makes it a credible additional origin for buyers reducing single-country dependency. We place your requirement with a qualified Indian producer and assemble the DMF, CEP, written confirmation and quality pack a second-source qualification needs, so the diversification is backed by a reviewable dossier, not just a new vendor.
Tell us the molecule and the market
Send the API, the target pharmacopoeia and the destination market. The Mumbai desk will confirm the regulatory route, shortlist qualified Indian producers with their DMF or CEP status, and return a documentation plan under a confidentiality agreement. If your requirement is the finished medicine rather than the bulk substance, ask for the finished-dose export path instead.