Aarise Pharmaceuticals vs Curia Global: CDMO vs CRO Liability

Signing with a contract manufacturer moves the work, not the accountability. Under the Food and Drug Administration's (FDA) quality-agreement guidance, the company that owns a drug stays legally responsible for approving or rejecting it, even when a contract facility made it. A longer service list does not move that responsibility. What you can verify about the site does.

The labels still matter for what you buy. A contract research organization (CRO) is hired for studies and their data. A contract development and manufacturing organization (CDMO) is hired for a formulation, process or active pharmaceutical ingredient (API) made to specification. Most programs use both at different stages, and some providers sell both under one name.

The practical test is therefore not which label a provider uses but whether you can check its site, its records and its quality agreement before the first batch ships. That test applies equally to a CRO, a CDMO and a supplier of APIs.

• The owner's quality unit is legally responsible for approving or rejecting product made by a contract facility, including final release (FDA, November 2016). A quality agreement does not change that.
• Choosing a CDMO or CRO does not change who is accountable: the owner's quality unit approves or rejects the batch and must audit the site.
• Seven written tests, listed below, tell you whether any provider's site and paperwork will stand up. Run them on every shortlisted provider, including us.

A CDMO develops and manufactures a drug product or API to a specification. A CRO produces research and clinical evidence about a drug. Buy from a CDMO when the deliverable is a physical batch, and from a CRO when the deliverable is data from a study.

You are. FDA's guidance states that when an owner uses a contract facility, "the owner's quality unit is legally responsible for approving or rejecting drug products manufactured by the contract facility, including for final release" (FDA, Contract Manufacturing Arrangements for Drugs: Quality Agreements, November 2016).

The same guidance adds: "No matter who tests the products, the owners' quality units are ultimately responsible for ensuring that the products are manufactured in accordance with CGMP. A quality agreement does not change that." CGMP means current good manufacturing practice, the baseline quality rules for drug makers. FDA also says an owner can be cited for failing to evaluate, qualify, audit and monitor its contract facilities.

For a study, the sponsor remains accountable for oversight of anything it transfers to a CRO, and only obligations described in writing are transferred (21 CFR 312.52).

Most buyers get this wrong in one direction: they treat the contract as a transfer of quality responsibility. It transfers work. The FDA guidance lists the usual quality agreement sections: purpose and scope, definitions, resolution of disagreements, manufacturing activities (including change control) and the agreement's life cycle.

Run seven written tests on every provider and give each a pass or a fail before you sign. Tests 2 to 5 follow the FDA quality-agreement guidance; tests 1, 6 and 7 are our recommendations.

A Drug Master File (DMF) is a confidential submission to FDA describing an API's manufacturing and quality. A Certificate of Suitability (CEP) is a European certificate confirming an API meets the European Pharmacopoeia monograph. A Certificate of Pharmaceutical Product (CPP) is a regulator-issued certificate on a product's status in the country that exports it.

Run the seven tests on the specific site that will make your product.

The facts below are our own, confirmed by our team, and Curia's as published on its website as of October 2026.

Curia's published scope also includes biologics and sterile drug product; this page compares oral-dose and API supply only.

Choose us when your need is a defined oral-dose product or API and you want to start small. Five reasons, each tied to a fact:

1. A single route for oral dose forms. We provide product development through commercial manufacturing for oral dosage forms. Our finished-dose catalogue also lists tablets, capsules, oral liquids, dry syrup, ointments, injections and external applications. The route is inquiry, feasibility review, commercial quotation, development or technical transfer, production and quality control, packaging and dispatch.
2. You can evaluate before you commit. We support sample and evaluation quantities for qualified business buyers. After successful evaluation and approval, we support the commercial and bulk requirement. Available documents include the COA, specifications and safety data sheets where applicable.
3. Small peptide batches. We support commercial peptide API supply and small clinical peptide batches of 5 grams, and good manufacturing practice (GMP) peptide manufacturing, with the manufacturing source and its certificates confirmed per product at quotation. The portfolio includes semaglutide, tirzepatide, liraglutide and other peptide raw materials, supplied as bulk API powder, not finished vials.
4. Steroid and hormone APIs in small batches. We support small steroid API batches and complex hormone API manufacturing. Documentation available per product includes COA, specifications and SDS/MSDS where applicable; confirm filing support for your product at quotation.
5. Importers and Latin American buyers. We provide documentation and supply support for US importers, and we communicate in English and in Spanish. Many anabolic steroids, testosterone among them, are Schedule III controlled substances under the US Controlled Substances Act, so importing them requires Drug Enforcement Administration (DEA) authorization (DEA Diversion Control Division), and DEA Form 236 is the related import declaration. Before commercial supply, the buyer confirms local registration, import authorization and permitted end use. Some materials may be restricted, controlled or limited to research or evaluation in certain jurisdictions, and we do not present such materials as approved human pharmaceutical APIs unless their status and documents establish that use.

How do I ask Aarise Pharmaceuticals for a quote?

Send the product name or CAS number (the Chemical Abstracts Service registry number), quantity, destination country, grade or purity, documents needed, payment terms and Incoterms (international trade delivery terms). Reach our sales team on WhatsApp or phone at +91 9899783330, by email at sunil@aarisepharma.com, or through our contact form. We respond during Indian business hours.

Compare seven points: the dosage-form line, peptides, steroid and hormone APIs, quote and lead time, import documentation, market experience and the contact route. Each can be checked with either company in writing.

Does the provider's dosage-form line match your product?

We build around oral dosage forms. Curia's finished-dose line, as published on its sterile drug product page, is sterile drug product, covering solutions, suspensions, emulsions, lipid nanoparticles and lyophilized dosage forms. If your product is a tablet, capsule or oral liquid, our stated line matches it.

In what form is the peptide delivered?

We supply peptide APIs as bulk API powder for business buyers, not as finished lyophilized peptide vials. Curia lists peptides within sterile drug product, with liquid and lyophilized formulations at commercial scale. If you want peptide raw material to formulate yourself, ask each provider which form it delivers.

How specific is the steroid and hormone list?

We name the molecules: testosterone, nandrolone, drostanolone and trenbolone derivatives, methenolone enanthate, boldenone undecylenate, stanozolol and oxandrolone. Curia lists Steroids & Hormones as a service area next to High Potency API (HPAPI) and Controlled Substances. In either case, ask for a molecule-level list tied to your CAS number.

How are price, minimum order and lead time confirmed?

Our prices vary by product, so each quotation is based on the current rate once you give the API name and its CAS number. Minimum order quantity (MOQ) and lead time are confirmed product by product after we check stock, manufacturing schedule, quality release and documentation, and they are stated in the quotation or proforma invoice.

What documentation supports an import?

We review availability and applicable documentation for the specific requirement and destination market, and we provide documentation and supply support for US importers. The buyer remains responsible for local registration, import authorization and permitted end use.

Where has the provider supported customers?

We have experience supporting customers in the USA, Mexico, Peru, Brazil, Canada, Germany and other regions, with communication in English and, for Latin American customers, Spanish. Curia reports 20+ facilities across North America, Europe and India on its home page.

How do you reach a person?

You reach our sales team directly on WhatsApp or phone at +91 9899783330 or by email, and our web form accepts product, partnership or distribution, investment, media and other inquiries. Curia directs new projects to a Contact Us page.