Metoclopramide Injection 10mg/2mL

Metoclopramide Injection 10mg/2mL: What the Published Guidance Says

Acid-suppression and antiemetic agents supplied as injectables and orals, including the proton-pump inhibitor and the two antiemetics carried on the WHO Model List.

Before Metoclopramide Injection 10mg/2mL is quoted, we confirm the monograph, the strength on the artwork and the release testing required by your market — the points summarised here.

• The antiemetics and their age limits Section 17.2 carries metoclopramide injection 5 mg/mL in 2 mL ampoule and 10 mg tablets, with a Model List note that it is not for use in neonates. Ondansetron is listed as injection 2 mg base/mL in 2 mL ampoule, oral liquid 4 mg base/5 mL, and solid oral forms equivalent to 4, 8 and 24 mg base, indicated above one month of age. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
• Dexamethasone doubles as an antiemetic Dexamethasone injection 4 mg/mL is listed in the antiemetic section as well as under antiallergic and palliative-care medicines — useful context when building a chemotherapy-support or post-operative nausea kit. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
• A note on ranitidine Ranitidine appears in section 17.1 of the Model List as an antiulcer medicine, with injection, oral liquid and 150 mg tablet presentations. Since 2020 it has been subject to market-level regulatory action in several countries relating to nitrosamine (NDMA) impurities. Confirm current local registration and monograph status before ordering. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)

Each point above is reproduced because it has a practical consequence for Metoclopramide Injection 10mg/2mL: the strength you can register, the pack you can release, or the wording permitted on the label. Your national prescribing information always takes precedence.

Metoclopramide Injection 10mg/2mL — Supply Parameters

The same therapeutic range is supplied in several presentations, so one purchase order can cover a mixed requirement: Cimetidine Injection 2mL:400mg Ampoule, Omeprazole Powder for Injection 40mg, Ondansetron Injection 4mg/2mL, Omeprazole 20mg Capsules, Ranitidine 150mg Capsules.

Quality Control, Pharmacopoeial Standards & Documentation

Products are manufactured and tested against USP, EP, BP and CP monographs, with incoming raw-material inspection, in-process monitoring and full finished-product testing.

Release testing for Metoclopramide Injection 10mg/2mL follows the monograph you nominate — USP, EP, BP or CP. If the presentation is not covered by a monograph, the specification is frozen in writing with your quality team before the batch is manufactured.

Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.

A typical release panel for this presentation covers:

• Testing for uniformity of dosage units
• Testing for water content and pH where applicable
• Testing for sterility and bacterial endotoxins (parenterals and ophthalmics)
• Testing for microbial limits and preservative efficacy (multi-dose presentations)
• Testing for heavy metals and elemental impurities
• Testing for packaging integrity and seal testing

COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.

Packaging, Labelling & Export

• Shelf life: 36 months (unopened). Stability data for the marketed pack is included in the dossier.
• Labelling: artwork can be produced in English, Arabic, French, Russian and Spanish, with your own brand and language mix, subject to the labelling rules of the destination market.
• Export: GMP certificate, COA, certificate of origin, packing list and, where required, the free-sale or marketing authorisation certificate from the country of manufacture.

Registration, Dossier & Tender Support

The legal manufacturer named on every document for Metoclopramide Injection 10mg/2mL is Sinophare Bio-technology Co., Ltd., DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. The same entity appears on the GMP certificate and on the dossier submitted to your regulator.

• Tender and framework documentation, including pre-qualification questionnaires and sample logistics.
• Artwork and mock-up approval pack, showing the carton, label and leaflet exactly as they will be printed for your market.
• Batch manufacturing and packaging records released for inspection on request during supplier audits.
• Re-test or renewal support when the marketing authorisation comes up for variation or renewal.
• CTD dossier modules 1–5 in editable and PDF form, with the finished-product and API sections cross-referenced.

Metoclopramide Injection 10mg/2mL is presented here against gastrointestinal and antiemetic medicines named in the WHO Model List. Inclusion in an essential-medicines list does not authorise sale in any particular country — the marketing authorisation for that market is a separate step.

Related GI & Antiemetics Products

• Cimetidine Injection 2mL:400mg Ampoule — 400mg/2mL
• Omeprazole Powder for Injection 40mg — 40mg
• Ondansetron Injection 4mg/2mL — 4mg/2mL
• Omeprazole 20mg Capsules — 20mg
• Ranitidine 150mg Capsules — 150mg

Browse the full GI & Antiemetics range; all Injectables; the complete product catalogue.