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Pharmaceutical Intermediates

Bulk Pharma Intermediates

Bulk key starting materials and process intermediates for established generic APIs, supplied at commercial scale with consistent specifications.
22 productsCOA + SDS with every lot
22 products
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Bulk Pharma Intermediates lists the compounds generic API makers buy by the drum. These are established intermediates and key starting materials with known routes and steady demand. Examples include (±)-3-(Carbamoylmethyl)-5-methylhexanoic acid (CMH) and its R-isomer used in pregabalin synthesis, 1-(4-Chlorobenzhydryl)piperazine for antihistamines, HEEP for quetiapine, (R)-(+)-α-Phenylethylamine as a resolving agent and 1,3-Difluorobenzene.

At this scale, buyers focus on assay, specified impurities, isomer content and lot-to-lot consistency, along with price and lead time. Change notification matters too, since a route change at the supplier can affect your API impurity profile and your filing. We discuss specification and change control with you before the first commercial order.

Material ships in lined drums or bags, palletised for container loading from Nhava Sheva or Mundra. Each lot comes with a COA and SDS, and pre-shipment samples can be arranged for qualification. Send annual volumes through our RFQ form for scheduled supply.

Bulk Pharma Intermediates: questions buyers ask

What is a key starting material in API manufacture?
A key starting material is a compound that contributes a significant structural fragment to the API and marks the point where regulatory controls on the synthesis begin. Its specification, supplier and route are described in the API filing. Changes to it can need regulatory notification, so consistent supply is important.
Why is CMH important in pregabalin production?
Racemic 3-(carbamoylmethyl)-5-methylhexanoic acid is resolved to give the R-isomer, which undergoes a Hofmann rearrangement to form pregabalin. The isomer purity of R-CMH directly affects the enantiomeric purity of the final API. Specify chiral purity and related impurity limits when sourcing it.
Can you notify us of route or site changes?
For agreed commercial supply, we can commit to notifying you of significant changes to the manufacturing route or site before they affect deliveries. This allows you to assess the impact and, if required, notify your regulator. Discuss the change notification terms when setting up your supply agreement.

Have a list of compounds to price?

Paste up to 200 CAS numbers into Bulk CAS lookup, or send one enquiry for everything in your quote list. We reply with price, lead time and documents.

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