The first order with a new plant is where most problems begin, and most of them could have been caught earlier. A late batch, a cream that separates in the summer, a tube that leaks at the crimp: each one costs you a doctor's trust in a product you spent months promoting.
This page is a checklist to work through before you pay an advance to a pharma ointment manufacturer. Run it on the companies listed above. It takes a few days, which is far cheaper than fixing a bad first batch in the market.
Visit the plant
Go yourself if you can. Two hours on the shop floor tell you more than any brochure. In the semi-solid section, look at these:
- The mixing and homogenising vessel, its working capacity in kg, and whether it has vacuum and a heating jacket
- The tube filling and sealing machine, and whether it runs both lami and aluminium tubes
- Cleaning records between products, especially where steroid and non-steroid creams share equipment
- The QC lab: whether staff are actually testing samples or the room is only shown to visitors
- Where finished goods and retention samples are stored
Notice how people answer. A plant that will not show the QC lab or the filling area is telling you something, even if the rate is attractive.
Licence and product permissions
Ask for the manufacturing licence copies (Form 25 and Form 28 for allopathic drugs) and check that the name and address match the plant you visited. Then ask for the product permission list and find each of your products on it, with the exact composition and strength. If a product is shown as "applied for", note it and do not print its cartons yet.
Ask how the plant meets Revised Schedule M, and whether it holds a WHO-GMP certificate if your buyers ask for one. Take copies of whatever they claim. A logo on a website or a visiting card is not a certificate. Some companies on this site carry a licence-checked badge, which means their licence details were checked. Product permissions still need your own check, product by product.
Sample batch and stability data
Before a full order, ask for samples of your products in the actual tube you will sell. Use them for a few weeks. See how they spread, smell and look. Leave one tube in a warm room and check whether it separates or oil seeps out. Hand a few to dermatologists you work with and write down what they say.
Then ask for stability data for each product in that pack. Accelerated and real-time studies are what support the expiry date printed on the tube. If the plant has no data for your exact formula, ask how it will set the shelf life. Also ask for a COA on the sample batch. It shows you whether the lab can actually test what it says it can.
Complaints, recalls, payment and dispatch
Ask how a market complaint is handled. Who do you write to, how soon will they respond, and will they test their retention samples from that batch? Ask whether there is a written recall procedure, and who pays if a batch has to be withdrawn because of a manufacturing fault. Get these answers into the agreement, not just on a phone call.
Then fix the money and logistics terms in writing:
Payment: advance amount, when the balance is due, and how long the rate stays valid. Packing material: who bears the cost of printed tubes and cartons that become useless if you change the artwork. Dispatch: time from final artwork approval to dispatch, mode of transport, freight terms, and how breakage or short supply is settled.
A pharma ointment manufacturer that is clear and open on these points at the start is usually easier to deal with when something goes wrong later.
Use this page to build your shortlist
Post your requirement through the form here with your product list (composition, strength, fill weight, tube type), quantity per batch and target date. Add a line saying you want a plant visit and a sample batch before you order. Posting is free and your number is not published. Matching plants will call you, and you can run this checklist on every pharma ointment manufacturer that makes your shortlist.
Related pages: Liquid & Dry Syrup Manufacturers and Pharma Tablet Manufacturers. Molecules most listed here: Clobetasol, Mometasone, Beclomethasone.
