WHO-GMP & CEP Accredited Manufacturer
Active Pharmaceutical
Ingredients Portfolio
High-purity APIs manufactured in our WHO-GMP certified facility at Ankleshwar, Gujarat — supplying regulated and emerging markets worldwide to IP, BP, EP & USP standards.
🇧🇷 Anvisa
🇪🇺 EDQM CEP
🇰🇷 MFDS Korea
🇮🇳 WHO-GMP
29
API Products
2
In Pipeline
4
Pharmacopeias
Certification Flag Legend — What Each Flag Means
Status colours:
Accredited
= Fully certified / compliant
Under Filing
= Application submitted, awaiting approval
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Product Image
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Product Details
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Regulatory & Compliance
API Portfolio FAQs
Common questions about our APIs, grades, certifications and documentation.
How many APIs does Reine Lifescience manufacture?
27 commercial APIs, plus 2 APIs under development (Bempedoic Acid, Iopamidol).
Which therapeutic areas does the API portfolio cover?
Cardiovascular, anti-diabetic, CNS/pain, anti-allergic, respiratory, iron chelation, anti-TB, oncology support and more.
Which pharmacopoeia grades are available?
APIs are supplied to IP, BP, EP and USP grades, or in-house (IH) specification, as shown in the table above.
Which certifications apply to these APIs?
WHO-GMP, EDQM CEP, MFDS Korea and ANVISA Brazil, as marked per product. See certifications.
Is a DMF available for these APIs?
Yes, for selected APIs. The DMF column above shows availability for each product.
Can I get a CoA, specification or sample?
Yes. Click View on any product or contact us with product, grade and quantity.
Does Reine Lifescience export these APIs?
Yes, to regulated and semi-regulated markets worldwide, with regulatory documentation support.
Where are these APIs manufactured?
At Reine Lifescience's cGMP facility in GIDC Ankleshwar, Gujarat, India.