Cimetidine Injection 2mL:400mg Ampoule

Cimetidine Injection 2mL:400mg Ampoule: 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.

This page collects the supply-relevant facts for Cimetidine Injection 2mL:400mg Ampoule — specification, testing, packaging and the registration paperwork that travels with the batch.

• 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)
• Omeprazole is the listed proton-pump inhibitor Section 17.1 of the Model List carries omeprazole as powder for injection 40 mg in vial, powder for oral liquid, and solid oral dosage forms of 10, 20 and 40 mg, for gastro-oesophageal reflux disease. It was first added in 2009. Therapeutic alternatives are the A02BC proton-pump inhibitor subgroup, excluding combinations. The 2025 revision replaced the 20 mg and 40 mg oral-liquid sachets with 1 mg/mL and 4 mg/mL powders for oral liquid. WHO eEML — Omeprazole
• 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)

We quote these sources rather than paraphrase them loosely, because the detail matters commercially for Cimetidine Injection 2mL:400mg Ampoule. Where your national list differs from the WHO listing, the national list governs what may be supplied and promoted locally.

How Cimetidine Injection 2mL:400mg Ampoule Is Tested and Released

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.

Every batch of Cimetidine Injection 2mL:400mg Ampoule is tested to the monograph stated on the purchase order. Where a monograph is silent on the presentation, we agree a written specification with you in advance and reference it on the certificate of analysis.

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

Release testing on this presentation is built around:

• Testing for related substances and impurities
• Testing for dissolution or release profile (solid oral forms)
• 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)

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

How Cimetidine Injection 2mL:400mg Ampoule Is Packed, Labelled and Shipped

• Pack size: 2mL amber glass ampoule. Non-standard pack sizes can be quoted against your artwork.
• Storage: Store below 25°C, protected from light. Do not freeze. Keep ampoule in outer carton until use..
• 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.

Regulatory Support for Cimetidine Injection 2mL:400mg Ampoule

Documents for Cimetidine Injection 2mL:400mg Ampoule are issued by Sinophare Bio-technology Co., Ltd. — DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. Keeping one legal manufacturer across the COA, the GMP certificate and the registration file avoids assessment queries later.

• Method validation, stability protocol and the shelf-life justification for the marketed pack.
• Answers to authority questions during assessment, handled by the regulatory contact who prepared the file.
• 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.

The context for Cimetidine Injection 2mL:400mg Ampoule is its place among gastrointestinal and antiemetic medicines named in the WHO Model List. Listing status informs how programmes specify a product; it is not a substitute for the import licence or marketing authorisation of the destination country.