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US FDA GMP EU GMP Has US DMF Has CEP No regulatory action Sample available APIs only Excipients only

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Segment determines which GMP annexe and filings apply.

Active Pharmaceutical IngredientsThe substance responsible for the therapeutic effect, as defined by ICH Q7.0Key Starting MaterialsA raw material or intermediate incorporated as a significant structural fragment of the API.0IntermediatesA material produced during API synthesis that undergoes further molecular change before becoming the API.0Pharma Raw MaterialsSolvents, reagents and process chemicals consumed in manufacture but not present in the final product.0ExcipientsInactive substances formulated alongside the API — binders, fillers, coatings and the rest.1Finished Dose FormsProduct ready for patient administration — the packaged, dosed form.0Specialty & Niche ChemicalsHigh-potency, controlled or otherwise specialised materials needing dedicated handling.0

A filed DMF or CEP is what lets your regulatory team reference this supplier in a submission.

Active US DMF (Type II)Drug Master File filed with the FDAEuropean ASMF filedActive Substance Master FileCEP / COS (EDQM)Ph.Eur. compliance certified by EDQMCoPP availableCertificate of Pharmaceutical Product

Excludes suppliers with a current FDA import alert, an open warning letter, or an EU GMP non-compliance.

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India1

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kg

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Computed from your own requirement — see the score breakdown for the components.

Microcrystalline Cellulose

Aurobindo Pharma · India

CAS: 9004-34-6
MOQ: 500 kg
Grade: NF / EP
Price: $2.1–2.8
Lead time: 2 weeks

ExcipientsFiller / diluentUS FDA GMPCDSCO