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Calcitonin Salmon Injection

As of 13 November 2026, for Calcitonin Salmon Injection, 5 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 1 holder.

Companies, stages and changes, with each record available on this page.

Listed in the US FDA Orange Book as MIACALCIN (NDA 017808, MYLAN IRELAND LTD).

Last 90 days: Accepted: 1 application

Current coverage may be incomplete

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Complete CDE snapshot
2026/11/13 06:42
Matching scope
Same generic name; dosage forms and combinations kept separate

US Orange Book listing

The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.

Orange Book source export date: 2026/11/06. Version: 2026-11-06.

Showing 2 of 2 distinct brand names.

A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.

Verified official English dosage form: Injection. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.

Same dosage form

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
MIACALCIN MYLAN IRELAND LTD NDA 017808 · Product no. 002 INJECTABLE INJECTION HUMAN PRESCRIPTION DRUG 1991/03/29
CALCIMAR SANOFI AVENTIS US LLC NDA 017497 · Product no. 001 INJECTABLE INJECTION DISCONTINUED Approved prior to 1982 (exact date not listed)
CALCIMAR SANOFI AVENTIS US LLC NDA 017769 · Product no. 001 INJECTABLE INJECTION DISCONTINUED Approved prior to 1982 (exact date not listed)
MIACALCIN MYLAN IRELAND LTD NDA 017808 · Product no. 001 INJECTABLE INJECTION DISCONTINUED 1986/07/03

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
MIACALCIN SAPTALIS PHARMACEUTICALS LLC NDA 020313 · Product no. 002 SPRAY, METERED NASAL DISCONTINUED 1995/08/17

Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.

Ingredient cross-list details ↗

Which companies are listed, and at what stages?

Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.

Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.

Chemical-drug catalogue

Loaded records: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 0 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Future Health Pharma GmbHNovartis Pharma Stein AGH201702031996/01/151ml: 50IUImported originator drugCDE

Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.

NHSA drug codes

Loaded records: 10 distinct approval numbers and 7 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Yin Gu Pharmaceutical Co., Ltd. romanized国药准字H200700841ml:16.7μg(100IU)Category BXH05BAG120B002010100123NHSA
Beijing SL Pharmaceutical Co., Ltd.国药准字H200206941ml:8.3μg(50IU)Category BXH05BAG120B002010100148NHSA
Shenzhen Han Yu Pharma Co., Ltd. romanized国药准字H200403031ml:50IUCategory BXH05BAG120B002010100526NHSA
Jin Zhou Ao Hong Pharma Co., Ltd. romanized国药准字H201134031ml:100IUCategory BXH05BAG120B002010102042NHSA
Gui Lin Nan Yao Co., Ltd. romanized国药准字H200103611ml:8.3μg(50IU)Category BXH05BAG120B002010105206NHSA
Kunming Ji Da Pharmaceutical Co., Ltd. romanized国药准字J201501231ml:50IUCategory BXH05BAG120B002010105589NHSA
Future Health Pharma GmbH国药准字HJ201702031ml:50IUCategory BXH05BAG120B002010180481NHSA
Yin Gu Pharmaceutical Co., Ltd. romanized国药准字H200700841ml:16.7μg(100IU)Category BXH05BAG120B002010200123NHSA
Shenzhen Han Yu Pharma Co., Ltd. romanized国药准字H200403031ml:50IUCategory BXH05BAG120B002010200526NHSA
Jin Zhou Ao Hong Pharma Co., Ltd. romanized国药准字H201133061ml:50IUCategory BXH05BAG120B002010202042NHSA
Kunming Ji Da Pharmaceutical Co., Ltd. romanized国药准字J201501231ml:50IUCategory BXH05BAG120B002010205589NHSA
Future Health Pharma GmbH国药准字HJ201702031ml:50IUCategory BXH05BAG120B002010280481NHSA
Shenzhen Han Yu Pharma Co., Ltd. romanized国药准字H200403031ml:50IUCategory BXH05BAG120B002010300526NHSA
Yin Gu Pharmaceutical Co., Ltd. romanized国药准字H200404951ml:8.3μg(50IU)Category BXH05BAG120B002020100123NHSA
Beijing SL Pharmaceutical Co., Ltd.国药准字H200600562ml:20μgCategory BXH05BAG120B002020100148NHSA
Gui Lin Nan Yao Co., Ltd. romanized国药准字H200103611ml:8.3μg(50IU)Category BXH05BAG120B002020105206NHSA
Yin Gu Pharmaceutical Co., Ltd. romanized国药准字H200404951ml:8.3μg(50IU)Category BXH05BAG120B002020200123NHSA
Beijing SL Pharmaceutical Co., Ltd.国药准字H200600562ml:20μgCategory BXH05BAG120B002020200148NHSA
Beijing SL Pharmaceutical Co., Ltd.国药准字H200206941ml:8.3μg(50IU)Category BXH05BAG120B002030100148NHSA

Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.

Current under-review applications

Loaded records: 5 filings and 4 distinct first applicants.

Supplement 2 · Generic 3

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Yin Gu Pharmaceutical Co., Ltd. romanizedCYHB2650127Supplement2026/05/28Not stated by sourceCDE
Yin Gu Pharmaceutical Co., Ltd. romanizedCYHB2650126Supplement2026/05/28Not stated by sourceCDE
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Gansu Cheng Ji Bio Pharma Co., Ltd. romanizedCYHS2600078Generic2026/01/08Not stated by sourceCDE
Chengdu Giantech Hi-technology Development Co., Ltd.; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanizedCYHS2600070Generic2026/01/08Not stated by sourceCDE
Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized; Chengdu Li Er Pharma Co., Ltd. romanizedCYHS2502381Generic2025/07/05Not stated by sourceCDE
New generic filings in 2026

Loaded records: 2 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Gansu Cheng Ji Bio Pharma Co., Ltd. romanizedCYHS2600078Generic2026/01/08Not stated by sourceCDE
Chengdu Giantech Hi-technology Development Co., Ltd.; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanizedCYHS2600070Generic2026/01/08Not stated by sourceCDE
API registrations

Non-component matches: 7 companies with A status and 1 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
鲑降钙素 · No verified English nameChengdu Sheng Nuo Biopharmaceutical Co., Ltd. romanizedY20250001368IExact ingredient2025/12/25CDE
鲑降钙素 · No verified English nameHan Yu Pharma (Wuhan) Co., Ltd. romanizedY20220000343AExact ingredient2024/06/28CDE
鲑降钙素 · No verified English nameBeijing SL Pharmaceutical Co., Ltd.Y20190005817AExact ingredient—CDE
鲑降钙素 · No verified English nameBeijing Shi Qiao Biopharmaceutical Co., Ltd. romanizedY20190005483AExact ingredient2025/01/03CDE
鲑降钙素 · No verified English nameGui Lin Nan Yao Co., Ltd. romanizedY20190004083AExact ingredient2025/01/18CDE
鲑降钙素 · No verified English nameShenzhen Han Yu Pharma Co., Ltd. romanizedY20190002719AExact ingredient2024/01/17CDE
鲑降钙素 · No verified English nameShanghai Su Hao Yi Ming Pharmaceutical Co., Ltd. romanizedY20190002440AExact ingredient2025/05/24CDE
鲑降钙素 · No verified English nameQingdao Guo Da Biopharmaceutical Co., Ltd. romanizedY20190001652AExact ingredient2025/01/16CDE

A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.

What changed recently?

Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.

Trial registration does not mean an application will follow.

This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.

NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.

This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.

  1. 2026/08/24Accepted

    Solupharm Pharmazeutische Erzeugnisse GmbH; Future Health Pharma GmbH; Beijing Kang Chen Bio Technology Co., Ltd. romanized

    JTH2600175

    Fact date: 2026/08/24 · Site observation date: 2026/10/22

    View source ↗

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/13 06:42
Chemical-drug catalogue
Last successful update: 2026/11/13 06:39

Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.

Full API register
Last successful update: 2026/11/13 06:41
NHSA drug codes
Last successful update: 2026/11/05 06:45

The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.

NMPA drug delivery notices
Last successful update: 2026/11/12 18:32 · Current coverage may be incomplete

First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.

Drug Clinical Trial Registry and Information Disclosure Platform
Last successful update: 2026/11/13 08:09 · Current coverage may be incomplete

Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.

This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.

Public-product searches scanned: 7/30; discovered pending details: 13. Record counts in unscanned portions remain unknown.

Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.

Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.

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