Suppliers and packagers for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bpi Labs	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	214283	ANDA	BPI Labs LLC	54288-141-04	4 VIAL in 1 CARTON (54288-141-04) / 20 mL in 1 VIAL	2023-03-08
Meitheal	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	212130	ANDA	Meitheal Pharmaceuticals Inc.	71288-803-92	4 VIAL, SINGLE-DOSE in 1 CARTON (71288-803-92) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-803-91)	2021-01-15
Meitheal	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	212130	ANDA	Meitheal Pharmaceuticals Inc.	71288-803-21	4 VIAL, SINGLE-DOSE in 1 CARTON (71288-803-21) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-803-20)	2021-01-15
Mylan Labs Ltd	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	203859	ANDA	Mylan Institutional LLC	67457-386-81	4 VIAL in 1 CARTON (67457-386-81) / 20 mL in 1 VIAL (67457-386-00)	2021-01-26
Onesource Specialty	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	216390	ANDA	ARMAS PHARMACEUTICALS INC	72485-415-04	4 VIAL in 1 CARTON (72485-415-04) / 20 mL in 1 VIAL	2023-07-06
Onesource Specialty	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	216390	ANDA	ONESOURCE SPECIALTY PHARMA LIMITED	83270-000-04	4 VIAL in 1 CARTON (83270-000-04) / 20 mL in 1 VIAL	2023-04-30

Suppliers and packagers for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Last updated: April 25, 2026

Who Supplies Mycophenolate Mofetil Hydrochloride (API) and How Are They Identified?

Mycophenolate mofetil hydrochloride is not a widely standardized global “API hydrochloride” trade label in major regulatory and commercial supply datasets. In most markets, the drug substance is distributed as mycophenolate mofetil (MMF, free base/neutral form), with hydrochloride appearing primarily as a salt form used for specific intermediates, reference standards, or niche specifications rather than a universal API sales descriptor. That means supplier lists depend on whether the target is (1) MMF API (neutral form) or (2) a specific “mycophenolate mofetil hydrochloride” salt grade used for a formulation or analytical requirement.

Because you requested suppliers for “mycophenolate mofetil hydrochloride” specifically, a complete and accurate supplier list cannot be produced from the information available in this chat session without risking misidentification (confusing MMF API supply with the hydrochloride salt).

Supplier Landscape: What Is Typically Supplied Instead

Most commercial API supply chains for MMF center on:

• Mycophenolate mofetil (MMF) API (the marketed drug substance)
• Mycophenolic acid (indirect upstream or alternative product)
• Reference standards (analytical materials where salt/labeling can vary)

If “hydrochloride” is not the marketed API descriptor for your jurisdiction or buyer spec, the correct procurement channel is usually MMF API, not the hydrochloride salt label. This distinction is central for identifying valid suppliers and avoiding incorrect sourcing.

Actionable procurement check points

A compliant supplier short list for the exact label “mycophenolate mofetil hydrochloride” normally depends on:

• Exact product name in COA and SDS (including “hydrochloride”)
• Salt form confirmation in the supplier’s specification (test for chloride/salt identity, polymorph form if applicable)
• Regulatory listing under your target dossier type (e.g., US DMF vs. EU CEP, where present)

Without those exact naming and spec details, supplier claims can be unreliable.

Key Takeaways

• Mycophenolate mofetil hydrochloride is not the dominant global API supply descriptor versus MMF API.
• A supplier list for the hydrochloride salt label requires exact salt-form confirmation in COA/SDS/specs.
• Procurement should first validate whether your requirement is truly MMF hydrochloride or MMF API under your regulatory and formulation specs.

FAQs

1) Are there many suppliers for mycophenolate mofetil hydrochloride specifically?
Not at the same scale as MMF API. The hydrochloride label is often not the standard commercial API descriptor.

2) Can I source this as mycophenolate mofetil (MMF) and convert to hydrochloride?
Only if your target spec allows conversion and you can validate identity, salt form, and impurities under your quality system.

3) Do reference standard suppliers carry the hydrochloride salt?
Some do, because analytical standards can be supplied in specific salt forms, but availability varies by catalog and lot.

4) What documentation proves hydrochloride salt identity from a supplier?
A COA that explicitly states the hydrochloride form, plus spec tests supporting salt identity (and matching SDS naming).

5) Do major regulatory listings differentiate the hydrochloride salt form?
Often they differentiate the marketed drug substance name; salt-form granularity depends on the dossier and the exact product scope.